Last updated: 11/07/2018 16:05:22
The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Double-Dummy, Parallel Group, Factorial Design Trial to Assess the Efficacy and Safety of up to Six Weeks Treatment with 20mg, 40mg, or 80mg QD Doses of Carvedilol Controlled Release Formulation (COREG CR) or 10mg, 20mg, or 40mg QD doses of Lisinopril (Zestril) or a Combination of One of the Doses of Each Medication
Trial description: This is a randomized, double-blind, double-dummy, parallel group trial employing 15 cells of a 4x4 factorial design (no placebo)to compare the hypertensive effects in patients with Stage 1 and Stage 2 hypertension of carvedilol (20, 40 or 80 mg daily) alone, lisinopril (10, 20 or 40 mg daily) alone, and all combinations of the doses.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure
Timeframe: Baseline, Week 6.
Change from Baseline to Week 6 in Trough Diastolic Blood Pressure
Timeframe: Baseline, Week 6
Secondary outcomes:
Change from Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure
Timeframe: Baseline, Week 6
Change from Baseline to Week 6 in Trough Systolic Blood Pressure
Timeframe: Baseline, Week 6
Dose-response treatment estimates: Change from Baseline to Week 6 in 24 hour Mean DBP by ABPM (ambulatory blood pressure monitoring)
Timeframe: Baseline, Week 6
Change from Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 hour ABPM (ambulatory blood pressure monitoring)
Timeframe: Baseline, Week 6
Overall description of safety in each treatment group using adverse events, laboratory evaluations, ECG changes, vital sign changes, and withdrawal rates.
Timeframe: Weeks 1 through 48
Change from Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 hour ABPM
Timeframe: Morning BP, Baseline, Week 6
Change from Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM
Timeframe: Afternoon BP, Baseline, Week 6
Change from Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM
Timeframe: Night BP, Baseline, Week 6
Change from Baseline to Week 6 in Mean Trough sitting SBP and sitting DBP by Cuff Assessment
Timeframe: Baseline, Week 6
Diastolic responders, defined as ≥ 10 mmHg sitting (s)DBP reduction from Baseline or a sDBP of <90 / 80 millimeters (mm) of mercury (Hg) for non diabetic / diabetic subjects respectively (based on cuff trough measures)
Timeframe: Week 6
Interventions:
Drug: lisinopril
Drug: carvedilol controlled release formulation
Enrollment:
654
Observational study model:
Not applicable
Primary completion date:
2008-22-04
Time perspective:
Not applicable
Clinical publications:
Bakris GL, Iyengar M, Lukas MA, Ordronneau P, Weber M. Effect of Combining Extended Release Carvedilol and Lisinopril in Hypertension: Results of the COSMOS Study. J Clin Hypertens (Greenwich).
Medical condition
Hypertension
Product
carvedilol
Collaborators
Not applicable
Study date(s)
July 2006 to April 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Subject has given signed informed consent.
- Subject is male or female 18 years of age at the time informed consent is signed.
- Subject is taking ≥3 antihypertensive medications. (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications [e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications].)
- Subject has DBP =90 mmHg (or for diabetic subjects, DBP =80 mmHg) on two antihypertensive medications.
Inclusion and exclusion criteria
Inclusion criteria:
- Subject has given signed informed consent.
- Subject is male or female 18 years of age at the time informed consent is signed.
- At the Screening visit, subject has a documented history or current presentation with stage 1 or stage 2 hypertension (see Section 15.1, Appendix 1 and Section 15.4, Appendix 4) which meets one of the following criteria. Note: All blood pressures are mean sitting cuff pressures: Documented history of hypertension and receiving two antihypertensive medications with mean sDBP <90 mmHg or for diabetic subjects (defined as having an established diagnosis of diabetes or receiving treatment for diabetes), mean sDBP <80 mmHg. Subjects taking beta blockers, clonidine, or other antihypertensive medications where abrupt discontinuation would be of clinical concern must be tapered off the medication during the Washout/Placebo Run-in phase to avoid rebound hypertension. All subjects must be able to be safely withdrawn from all antihypertensive treatment during the Washout/Placebo Run-in phase. Subjects should not be enrolled if the investigator thinks it is likely the subject's mean sDBP will exceed 109 mmHg or their mean sSBP will exceed 180 mmHg during the Washout/Placebo Run-in phase (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications [e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications].) OR Receiving one antihypertensive medication with mean sDBP =109 mmHg and can be safely withdrawn from all antihypertensive medication during the Washout/Placebo Run-in phase. Any subject who is receiving beta-blockers, clonidine, or other antihypertensive medications where abrupt discontinuation would be of clinical concern must have the dose tapered down during the Washout/Placebo Run-in phase to avoid rebound hypertension. All subjects must be able to be safely withdrawn from all antihypertensive treatment during the Washout/Placebo Run-in phase. Subjects should not be enrolled if the investigator thinks it is likely the subject's mean sDBP will exceed 109 mmHg or their mean sSBP will exceed 180 mmHg during the Washout/Placebo Run-in phase. (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications [e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications]. OR Untreated/newly diagnosed subjects: mean sDBP =95 and =109, or for diabetic subjects, mean sDBP =85 and =109 (see Section 15.1, Appendix 1). If newly diagnosed, must have qualifying blood pressure confirmed on two consecutive visits with the mean sDBP value not differing more than 8 mmHg. (Previously untreated subjects include subjects who have not been treated for hypertension in the last two months.).
- Mean 12-hour daytime (9 AM to 9 PM) DBP ≥90 and ≤109mmHg (or for diabetic subjects, ≥80 and ≤109mmHg)
- At least 75% of the programmed readings properly recorded over 24-hour monitoring period
- No more than two non-consecutive hours with less than two successful readings per hour while awake, and no more than two consecutive hours with less than one successful reading per hour during the sleep period over the 24-hour monitoring period
- At least two successful readings per hour for three of the last four hours of recording (trough period i.e., 20-24 hour during which subjects must be awake) with a total of at least 7 successful readings over this period.
At Baseline: DAY BEFORE RANDOMIZATION: Prior to having the baseline ABPM equipment placed, subject has mean sitting cuff DBP that is ≥93 and ≤111 mmHg (or for diabetic subjects, ≥83 and ≤111 mmHg). Subjects who were taking antihypertensive medication at Screening and do not meet this criterion after one week (or 5 half-lives, whichever is longer), can return in one week ±1day and have his/her blood pressure evaluated again for this inclusion criterion. AND RANDOMIZATON DAY: After completion of the ABPM assessment, subject meets the following ABPM (both 12 hr and 24 hr) criteria (see Section 15.1, Appendix 1):
Exclusion criteria:
- Subject is taking ≥3 antihypertensive medications. (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications [e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications].)
- Subject has DBP =90 mmHg (or for diabetic subjects, DBP =80 mmHg) on two antihypertensive medications.
- Subject has any known contraindication to ACE inhibitors (e.g., ACE-induced cough, angioedema or negative renal effects), or blocker treatment.
- Hyperkalemia or history of hyperkalemia resulting from either Type IV RTA (renal tubular acidosis) or previous ACEi therapy.
- Is female of childbearing potential. NOTE: Female subjects who are postmenopausal (i.e., no menstrual period for a minimum of 12 months prior to Screening) or surgically sterilized are eligible for the study. If judged appropriate, a postmenopausal woman may be required to have a documented negative urine pregnancy test.
- Subject has malignant (accelerated) hypertension, history of malignant hypertension, or secondary forms of hypertension.
- Subject has mean sitting SBP =180 mmHg.
- Subject has advanced hypertensive retinopathy (Keith Wagner Grade IV).
- Subject has Type 1 diabetes mellitus, or those with Type 2 having HbA1c ≥9% at Screening.
- Subject has uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathies.
- Subject has any of the following conditions: uncontrollable or symptomatic arrhythmias unstable angina or angina treated with a beta-blocker sick sinus syndrome or second or third degree heart block (unless treated with a permanent, functioning pacemaker) bradycardia (sitting heart rate <55 bpm) history of myocardial infarction stroke within 3 months of Screening
- Subject is in atrial fibrillation.
- Subject has Congestive Heart Failure NYHA (New York Heart Association) class II-IV [The Criteria Committee of the New York Heart Association, 1994].
- Current clinical evidence of asthma or chronic obstructive pulmonary disease (e.g., severe emphysema or chronic bronchitis) requiring long term use of inhaled oral bronchodilator or steroid drug therapy; also subjects with a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with the study medication could provoke bronchospasm; or requirement for or anticipated treatment with beta-2 agonist therapy (e.g., albuterol [Ventolin, Proventil], metaproterenol [Alupent], pirbuterol [Maxair], terbutaline [Brethaire], isoetharine [Bronkosol], and Levalbuterol [Xopenex]).
- Subject has evidence of any of the following clinically significant diseases that could impair the absorption, metabolism, or excretion of orally-administered medication: renal disease defined as estimated Glomerular Filtration Rate (eGFR) <30mL/min per 1.73 m2 hepatic disease (i.e., ALT or AST levels greater than three times the upper limit of normal range, history of hepatic impairment, or by clinical assessment) chronic biliary disorders gastric bypass surgery
- Subject has endocrine disorders that affect blood pressure (e.g., pheochromocytoma, active and untreated hypo- or hyperthyroidism).
- Subject has systemic disease, including cancer, with reduced (<12 months) life expectancy.
- Subject has used an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Screening.
- Subject has a history of a psychological illness/condition that would interfere with their ability to understand or complete the requirements of the study.
- Subject has any condition that, in the opinion of the Investigator and/or the GSK Medical Monitor, places the subject at an unacceptable risk as a participant in this trial.
- Subject is receiving ongoing treatment or is anticipated to receive treatment with any of the following medications during treatment with double blind study medication: any antihypertensive medication except for assigned study medication. This would include alpha blockers or other medications that may be used to treat hypertension and other conditions unrelated to hypertension; monoamine oxidase (MAO) inhibitors; any Class I or III antiarrhythmic; beta-2-agonists.
Trial location(s)
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35235
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Warminster, Pennsylvania, United States, 18974
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08817
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28211
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vista, California, United States, 92084
Status
Study Complete
Location
GSK Investigational Site
Sandersville, Georgia, United States, 31082
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Havertown, Pennsylvania, United States, 19083
Status
Study Complete
Location
GSK Investigational Site
High Point, North Carolina, United States, 27262
Status
Study Complete
Location
GSK Investigational Site
Waco, Texas, United States, 76712
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Beverly Hills, California, United States, 90211
Status
Study Complete
Location
GSK Investigational Site
Beaver, Pennsylvania, United States, 15009
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76014
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
Palm Harbor, Florida, United States, 34684
Status
Study Complete
Location
GSK Investigational Site
Hilton Head Island, South Carolina, United States, 29926
Status
Study Complete
Location
GSK Investigational Site
Burbank, California, United States, 91505
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60607
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gilbert, Arizona, United States, 85296
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35216
Status
Study Complete
Location
GSK Investigational Site
Manassas, Virginia, United States, 20110
Status
Study Complete
Location
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
Status
Study Complete
Location
GSK Investigational Site
Chester, Virginia, United States, 23836
Status
Study Complete
Location
GSK Investigational Site
Wilmington, Delaware, United States, 19805
Status
Study Complete
Location
GSK Investigational Site
Loma Linda, California, United States, 92354
Status
Study Complete
Location
GSK Investigational Site
Manning, South Carolina, United States, 29102
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11203
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85308
Status
Study Complete
Location
GSK Investigational Site
Bloomington, Indiana, United States, 47102
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29309
Status
Study Complete
Location
GSK Investigational Site
Slidell, Louisiana, United States, 70458
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89016
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30066
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60610
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19154
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Jacksonville Beach, Florida, United States, 32250
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78224
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85023
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, Arizona, United States, 86106
Status
Study Complete
Location
GSK Investigational Site
Ridgewood, New Jersey, United States, 7450
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92705
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72204
Status
Study Complete
Location
GSK Investigational Site
Tonawanda, New York, United States, 14150-1810
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anniston, Alabama, United States, 36207
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Muscle Shoals, Alabama, United States, 35662
Status
Study Complete
Location
GSK Investigational Site
O Fallon, Montana, United States, 63366
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84102
Status
Study Complete
Location
GSK Investigational Site
Pico Rivera, California, United States, 90660
Status
Study Complete
Location
GSK Investigational Site
Missoula, Montana, United States, 59808
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Taylors, South Carolina, United States, 29687
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27615
Status
Study Complete
Location
GSK Investigational Site
Aurora, Illinois, United States, 60504
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33023
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Georgia, United States, 30501
Status
Study Complete
Location
GSK Investigational Site
Rancho Cordova, California, United States, 95670
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Taunton, Massachusetts, United States, 02780.
Status
Study Complete
Location
GSK Investigational Site
Doylestown, Pennsylvania, United States, 18901
Status
Study Complete
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08034
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fairfax, Virginia, United States, 22030
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29403
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Beaufort, South Carolina, United States, 29906
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Leetsdale, Pennsylvania, United States, 15056
Status
Study Complete
Location
GSK Investigational Site
Beuna Park, California, United States, 90620
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46250
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
Status
Study Complete
Location
GSK Investigational Site
Lewinston, New York, United States, 14092
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99206
Status
Study Complete
Location
GSK Investigational Site
Sumter, South Carolina, United States, 29150
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35242
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Study Complete
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35215
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93703
Status
Study Complete
Location
GSK Investigational Site
Haleyville, Alabama, United States, 35565
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20017
Status
Study Complete
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33013
Status
Study Complete
Location
GSK Investigational Site
Grand Prairie/Texas, Texas, United States, 5052
Status
Study Complete
Location
GSK Investigational Site
Landsdale, Pennsylvania, United States, 19446
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85225
Status
Study Complete
Location
GSK Investigational Site
Murray, Utah, United States, 84107
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Georgetown, Texas, United States, 78626
Status
Study Complete
Location
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
Status
Study Complete
Location
GSK Investigational Site
Selmer, Tennessee, United States, 38375
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87102
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33027
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89128
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16504
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85260
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19152
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45236
Status
Study Complete
Location
GSK Investigational Site
Brooklyn Center, Minnesota, United States, 55430
Status
Study Complete
Location
GSK Investigational Site
Carlsbad, California, United States, 92008
Status
Study Complete
Location
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80904
Status
Study Complete
Location
GSK Investigational Site
Sun City, Arizona, United States, 85351
Status
Study Complete
Location
GSK Investigational Site
West Chester, Pennsylvania, United States, 19380
Status
Study Complete
Location
GSK Investigational Site
Jackson, Tennessee, United States, 38305
Status
Study Complete
Location
GSK Investigational Site
Arlington, Virginia, United States, 22205
Status
Study Complete
Location
GSK Investigational Site
Sarasota, Florida, United States, 34239
Status
Study Complete
Location
GSK Investigational Site
Kingston, New York, United States, 12401
Status
Study Complete
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58103
Status
Study Complete
Location
GSK Investigational Site
Searcy, Arkansas, United States, 72143
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-22-04
Actual study completion date
2008-22-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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