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Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: February 14, 2008
Last updated: February 7, 2013
Last verified: February 2013
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.

Condition Intervention Phase
Drug: carvedilol controlled release/lisinopril
Drug: lisinopril + placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose.

Secondary Outcome Measures:
  • Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Mean change was calculated as Week 6 values minus Baseline values.

Enrollment: 348
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carvedilol CR + lisinopril Drug: carvedilol controlled release/lisinopril
carvedilol CR + lisinopril given as separate pills
Active Comparator: lisinopril + placebo Drug: lisinopril + placebo
lisinopril plus placebo to match carvedilol CR


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 </=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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00624065

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United States, Alabama
GSK Investigational Site
Mobile, Alabama, United States, 36617
United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 77030
GSK Investigational Site
Glendale, Arizona, United States, 85308
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Goodyear, Arizona, United States, 85395
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Litchifield Park/Arizona, Arizona, United States, 85340
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Phoenix, Arizona, United States, 85032
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Tucson, Arizona, United States, 85745
United States, California
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Anaheim, California, United States, 92801
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Beuna Park, California, United States, 90620
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Fountain Valley, California, United States, 92708
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Poway, California, United States, 92064
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San Ramon, California, United States, 94583
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Tustin, California, United States, 92780
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Vista, California, United States, 92081
United States, Florida
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Coral Gables, Florida, United States, 33134
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Deland, Florida, United States, 32720
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Fort Lauderdale, Florida, United States, 33308
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Hollywood, Florida, United States, 33023
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Miami, Florida, United States, 33156
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Pembroke Pines, Florida, United States, 33024
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Tamarac, Florida, United States, 33321
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West Palm Beach, Florida, United States, 33409
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Atlanta, Georgia, United States, 30342
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Savannah, Georgia, United States, 31406
United States, Idaho
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Nampa, Idaho, United States, 83686
United States, Illinois
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Aurora, Illinois, United States, 60504
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Chicago, Illinois, United States, 60607
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Gillespie, Illinois, United States, 62033
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Elkhart, Indiana, United States, 46514
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Indianapolis, Indiana, United States, 46250
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Indianapolis, Indiana, United States, 46260
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Wichita, Kansas, United States, 67205
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Wichita, Kansas, United States, 67207
United States, Kentucky
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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Slidell, Louisiana, United States, 70458
United States, Maryland
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Columbia, Maryland, United States, 21045
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Butte, Montana, United States, 59701
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Omaha, Nebraska, United States, 68134
United States, Nevada
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Las Vegas, Nevada, United States, 89016
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Las Vegas, Nevada, United States, 89119
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
United States, New York
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Buffalo, New York, United States, 14209
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Buffalo, New York, United States, 14215
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East Syracuse, New York, United States, 13057
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New York, New York, United States, 10075
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Westfield, New York, United States, 14787
United States, North Carolina
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Raleigh, North Carolina, United States, 27609
United States, North Dakota
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Fargo, North Dakota, United States, 58103
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Corvallis, Oregon, United States, 97330
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Altoona, Pennsylvania, United States, 16602
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Havertown, Pennsylvania, United States, 19083
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Jersey Shore, Pennsylvania, United States, 17740
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Lansdale, Pennsylvania, United States, 19446
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Philadelphia, Pennsylvania, United States, 19154
United States, South Carolina
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Columbia, South Carolina, United States, 29201
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Columbia, South Carolina, United States, 29204
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Manning, South Carolina, United States, 29102
United States, Tennessee
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Johnson City, Tennessee, United States, 37601
United States, Texas
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Austin, Texas, United States, 78705
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Georgetown, Texas, United States, 78626
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Grand Prairie, Texas, United States, 75052
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Houston, Texas, United States, 77081
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San Antonio, Texas, United States, 78224
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San Antonio, Texas, United States, 78229
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Sugar Land, Texas, United States, 77479
United States, Utah
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Draper, Utah, United States, 84020
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Magna, Utah, United States, 84044
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Salt Lake City, Utah, United States, 84109
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Salt Lake City, Utah, United States, 84121
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Sandy, Utah, United States, 84094
United States, Washington
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Bellingham/Washington, Washington, United States, 98226
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Gig Harbor, Washington, United States, 98335
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Olympia, Washington, United States, 98502-8151
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Tacoma, Washington, United States, 98405
United States, Wisconsin
GSK Investigational Site
Beloit, Wisconsin, United States, 53511
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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.

Responsible Party: GlaxoSmithKline Identifier: NCT00624065     History of Changes
Other Study ID Numbers: COR111096 
Study First Received: February 14, 2008
Results First Received: June 11, 2009
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
target blood pressure
carvedilol CR
Stage 1 or 2 essential hypertension

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents processed this record on December 02, 2016