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

November 4, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

348

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • GSK Investigational Site
    • Arizona
      • 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
        • GSK Investigational Site
    • California
      • 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
        • GSK Investigational Site
    • Florida
      • 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
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Savannah, Georgia, United States, 31406
        • GSK Investigational Site
    • Idaho
      • Nampa, Idaho, United States, 83686
        • GSK Investigational Site
    • Illinois
      • Aurora, Illinois, United States, 60504
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60607
        • GSK Investigational Site
      • Gillespie, Illinois, United States, 62033
        • GSK Investigational Site
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46250
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • GSK Investigational Site
      • Wichita, Kansas, United States, 67205
        • GSK Investigational Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • GSK Investigational Site
    • Louisiana
      • Slidell, Louisiana, United States, 70458
        • GSK Investigational Site
    • Maryland
      • Columbia, Maryland, United States, 21045
        • GSK Investigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89016
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • GSK Investigational Site
    • New York
      • Buffalo, New York, United States, 14215
        • GSK Investigational Site
      • Buffalo, New York, United States, 14209
        • 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
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • GSK Investigational Site
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • GSK Investigational Site
    • Pennsylvania
      • 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
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • GSK Investigational Site
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
      • Manning, South Carolina, United States, 29102
        • GSK Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • GSK Investigational Site
    • Texas
      • 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
        • GSK Investigational Site
    • Utah
      • 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
        • GSK Investigational Site
    • Washington
      • 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
        • GSK Investigational Site
    • Wisconsin
      • Beloit, Wisconsin, United States, 53511
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment
Time Frame: Week 6
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Mean change was calculated as Week 6 values minus Baseline values.
Baseline and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR111096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: COR111096
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: COR111096
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: COR111096
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: COR111096
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: COR111096
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: COR111096
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: COR111096
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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