Last updated: 11/07/2018 16:05:22

The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial

GSK study ID
CFD105453
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2008-22-04
    Observational study model:
    Not applicable
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Temple, Texas, United States, 76502
    Status
    Study Complete
    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
    Tucson, Arizona, United States, 85741
    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
    Cleveland, Ohio, United States, 44195
    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
    Tulsa, Oklahoma, United States, 74104
    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
    Cleveland, Ohio, United States, 44106
    Status
    Study Complete
    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
    Dayton, Ohio, United States, 45406
    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
    Miami, Florida, United States, 33156
    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
    Wichita, Kansas, United States, 67205
    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
    Houston, Texas, United States, 77081
    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
    Tucson, Arizona, United States, 85712
    Status
    Study Complete
    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
    Austin, Texas, United States, 78705
    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
    Omaha, Nebraska, United States, 68131
    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
    Mesa, Arizona, United States, 85206
    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
    Ames, Iowa, United States, 50010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sugar Land, Texas, United States, 77479
    Status
    Study Complete
    Location
    GSK Investigational Site
    Avon, Indiana, United States, 46123
    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
    Mobile, Alabama, United States, 36617
    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
    Burke, Virginia, United States, 22015
    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
    Longview, Texas, United States, 75605
    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
    Sandy, Utah, United States, 84094
    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
    Eugene, Oregon, United States, 97401
    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
    Miami, Florida, United States, 33169
    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
    Study complete
    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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