Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure
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
1 other identifier
interventional
348
1 country
76
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Mar 2008
Shorter than P25 for phase_3 hypertension
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
August 3, 2009
CompletedDecember 28, 2016
November 1, 2016
5 months
February 14, 2008
June 11, 2009
November 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment
Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose.
Week 6
Secondary Outcomes (1)
Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6
Baseline and Week 6
Study Arms (2)
carvedilol CR + lisinopril
EXPERIMENTALlisinopril + placebo
ACTIVE COMPARATORInterventions
carvedilol CR + lisinopril given as separate pills
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (76)
GSK Investigational Site
Mobile, Alabama, 36617, United States
GSK Investigational Site
Chandler, Arizona, 77030, United States
GSK Investigational Site
Glendale, Arizona, 85308, United States
GSK Investigational Site
Goodyear, Arizona, 85395, United States
GSK Investigational Site
Litchifield Park/Arizona, Arizona, 85340, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Tucson, Arizona, 85745, United States
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Anaheim, California, 92801, United States
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Beuna Park, California, 90620, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Poway, California, 92064, United States
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San Ramon, California, 94583, United States
GSK Investigational Site
Tustin, California, 92780, United States
GSK Investigational Site
Vista, California, 92081, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
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Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Hollywood, Florida, 33023, United States
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Miami, Florida, 33156, United States
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Pembroke Pines, Florida, 33024, United States
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Tamarac, Florida, 33321, United States
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West Palm Beach, Florida, 33409, United States
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Atlanta, Georgia, 30342, United States
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Savannah, Georgia, 31406, United States
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Nampa, Idaho, 83686, United States
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Aurora, Illinois, 60504, United States
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Chicago, Illinois, 60607, United States
GSK Investigational Site
Gillespie, Illinois, 62033, United States
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Elkhart, Indiana, 46514, United States
GSK Investigational Site
Indianapolis, Indiana, 46250, United States
GSK Investigational Site
Indianapolis, Indiana, 46260, United States
GSK Investigational Site
Wichita, Kansas, 67205, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
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Paducah, Kentucky, 42003, United States
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Slidell, Louisiana, 70458, United States
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Columbia, Maryland, 21045, United States
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Butte, Montana, 59701, United States
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Omaha, Nebraska, 68134, United States
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Las Vegas, Nevada, 89016, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Albuquerque, New Mexico, 87102, United States
GSK Investigational Site
Buffalo, New York, 14209, United States
GSK Investigational Site
Buffalo, New York, 14215, United States
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East Syracuse, New York, 13057, United States
GSK Investigational Site
New York, New York, 10075, United States
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Westfield, New York, 14787, United States
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Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Fargo, North Dakota, 58103, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Corvallis, Oregon, 97330, United States
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Altoona, Pennsylvania, 16602, United States
GSK Investigational Site
Havertown, Pennsylvania, 19083, United States
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Jersey Shore, Pennsylvania, 17740, United States
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Lansdale, Pennsylvania, 19446, United States
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Philadelphia, Pennsylvania, 19154, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Columbia, South Carolina, 29204, United States
GSK Investigational Site
Manning, South Carolina, 29102, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Georgetown, Texas, 78626, United States
GSK Investigational Site
Grand Prairie, Texas, 75052, United States
GSK Investigational Site
Houston, Texas, 77081, United States
GSK Investigational Site
San Antonio, Texas, 78224, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Sugar Land, Texas, 77479, United States
GSK Investigational Site
Draper, Utah, 84020, United States
GSK Investigational Site
Magna, Utah, 84044, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
Sandy City, Utah, 84094, United States
GSK Investigational Site
Bellingham/Washington, Washington, 98226, United States
GSK Investigational Site
Gig Harbor, Washington, 98335, United States
GSK Investigational Site
Olympia, Washington, 98502-8151, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Beloit, Wisconsin, 53511, United States
Related Publications (1)
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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 26, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
December 28, 2016
Results First Posted
August 3, 2009
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.