Last updated: 11/04/2018 05:58:54

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

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GSK study ID
COR111096
See study documents
Clinicaltrials.gov ID
NCT00624065
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2008-06-08
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85032
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Manning, South Carolina, United States, 29102
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Deland, Florida, United States, 32720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mobile, Alabama, United States, 36617
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bellingham/Washington, Washington, United States, 98226
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27609
    Status
    Study Complete
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    Showing 1 - 6 of 76 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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