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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: lisinopril + placebo; Drug: carvedilol controlled release/lisinopril

• Registration Number: NCT00624065
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-26
• Study Start: 2008-03
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-06-11
• Results First Submitted QC: 2009-06-11
• Results First Posted: 2009-08-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

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 Subjects taking one hypertensive medication had their medication withdrawn and entered a wash-out phase prior to randomization.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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lisinopril + placebo	lisinopril + placebo	-
carvedilol CR + lisinopril	carvedilol controlled release/lisinopril	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment	Week 6	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

Name	Time	Method
Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6	Baseline and Week 6	Mean change was calculated as Week 6 values minus Baseline values.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Beloit, Wisconsin, United States