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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: November 4, 2016
Last verified: November 2016

February 14, 2008
November 4, 2016
March 2008
August 2008   (Final data collection date for primary outcome measure)
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.
proportion of subjects with mean sitting cuff blood pressure <140/90mmHg at the end of 6 weeks treatment
Complete list of historical versions of study NCT00624065 on Archive Site
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.
change from baseline to Week 6 in mean sitting cuff SBP and DBP Overall description of safety in each treatment group using adverse events, laboratory evaluations, vital sign changes and withdrawal rates
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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
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Drug: carvedilol controlled release/lisinopril
    carvedilol CR + lisinopril given as separate pills
  • Drug: lisinopril + placebo
    lisinopril plus placebo to match carvedilol CR
  • Experimental: carvedilol CR + lisinopril
    Intervention: Drug: carvedilol controlled release/lisinopril
  • Active Comparator: lisinopril + placebo
    Intervention: Drug: lisinopril + placebo
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Patient-level data for this study will be made available through following the timelines and process described on this site.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP