Last updated: 11/04/2018 05:58:54
Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: COR111096, A Randomized, Double-Blind, Active-Controlled, Parallel Group, Multicenter Study Comparing the Proportion of Subjects with Stage 1 or 2 Essential Hypertension Who Achieve Target Blood Pressure While Receiving Either carvedilol CR + lisinopril or lisinopril Monotherapy
Trial description: Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of Participants with Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment
Timeframe: Week 6
Secondary outcomes:
Mean Change from Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6
Timeframe: Baseline and Week 6
Interventions:
Drug: carvedilol controlled release/lisinopril
Drug: lisinopril + placebo
Enrollment:
348
Observational study model:
Not applicable
Primary completion date:
2008-06-08
Time perspective:
Not applicable
Clinical publications:
GSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion.
Medical condition
Hypertension
Product
carvedilol
Collaborators
Not applicable
Study date(s)
March 2008 to August 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
No
- Male or female age 18-80 years; stage 1 or 2 hypertension currently receiving 0 or 1 antihypertensive medication; mean sitting systolic blood pressure >/=140mmHg to </=170mmHg, or mean sitting diastolic blood pressure >/=90 to </=105mmHg. Subjects taking one hypertensive medication had their medication withdrawn and entered a wash-out phase prior to randomization.
- Subject taking two or more antihypertensive medications, known contraindication to angiotensin-converting enzyme (ACE) inhibitors or alpha- or beta-blocker therapy, subject has Type 1 or Type 2 diabetes
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female age 18-80 years; stage 1 or 2 hypertension currently receiving 0 or 1 antihypertensive medication; mean sitting systolic blood pressure >/=140mmHg to /=90 to
Exclusion criteria:
- Subject taking two or more antihypertensive medications, known contraindication to angiotensin-converting enzyme (ACE) inhibitors or alpha- or beta-blocker therapy, subject has Type 1 or Type 2 diabetes
Trial location(s)
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Study Complete
Location
GSK Investigational Site
Manning, South Carolina, United States, 29102
Status
Study Complete
Location
GSK Investigational Site
Bellingham/Washington, Washington, United States, 98226
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29204
Status
Study Complete
Location
GSK Investigational Site
Gillespie, Illinois, United States, 62033
Status
Study Complete
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58103
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33023
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Corvallis, Oregon, United States, 97330
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
Philadelphia, Pennsylvania, United States, 19154
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
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
Georgetown, Texas, United States, 78626
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Beuna Park, California, United States, 90620
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Study Complete
Location
GSK Investigational Site
Litchifield Park/Arizona, Arizona, United States, 85340
Status
Study Complete
Location
GSK Investigational Site
Havertown, Pennsylvania, United States, 19083
Status
Study Complete
Location
GSK Investigational Site
Tustin, California, United States, 92780
Status
Study Complete
Location
GSK Investigational Site
San Ramon, California, United States, 94583
Status
Study Complete
Location
GSK Investigational Site
Grand Prairie, Texas, United States, 75052
Status
Study Complete
Location
GSK Investigational Site
Beloit, Wisconsin, United States, 53511
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 77030
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Aurora, Illinois, United States, 60504
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14209
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
Gig Harbor, Washington, United States, 98335
Status
Study Complete
Location
GSK Investigational Site
Columbia, Maryland, United States, 21045
Status
Study Complete
Location
GSK Investigational Site
Elkhart, Indiana, United States, 46514
Status
Study Complete
Location
GSK Investigational Site
Westfield, New York, United States, 14787
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Olympia, Washington, United States, 98502-8151
Status
Study Complete
Location
GSK Investigational Site
Goodyear, Arizona, United States, 85395
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60607
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92081
Status
Study Complete
Location
GSK Investigational Site
Poway, California, United States, 92064
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10075
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46250
Status
Study Complete
Location
GSK Investigational Site
Lansdale, Pennsylvania, United States, 19446
Status
Study Complete
Location
GSK Investigational Site
Tamarac, Florida, United States, 33321
Status
Study Complete
Location
GSK Investigational Site
Paducah, Kentucky, United States, 42003
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85308
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16602
Status
Study Complete
Location
GSK Investigational Site
Jersey Shore, Pennsylvania, United States, 17740
Status
Study Complete
Location
GSK Investigational Site
East Syracuse, New York, United States, 13057
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78224
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
2008-06-08
Actual study completion date
2008-06-08
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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