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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.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00624065
First received: February 14, 2008
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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
Hypertension
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
Other Name: carvedilol controlled release/lisinopril
Active Comparator: lisinopril + placebo Drug: lisinopril + placebo
lisinopril plus placebo to match carvedilol CR

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </=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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624065

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov 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
hypertension
COREG CR
carvedilol CR
Stage 1 or 2 essential hypertension
lisinopril

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Carvedilol
Lisinopril
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014