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

Condition(s) targeted: Stage 1 or 2 Essential Hypertension

Intervention: carvedilol controlled release/lisinopril (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK GSK, MD, Study Director, Affiliation: GlaxoSmithKline

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 received either COREG 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.

Official title: COR111096, A Randomized, Double-Blind, Active-Controlled, Parallel Group, Multicenter Study Comparing Teh Proportion of Subjects With Stage 1 or 2 Essential Hypertension Who Achieve Target Blood Pressure While Receiving Either COREG CR + Lisinopril or Lisinopril Monotherapy

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: proportion of subjects with mean sitting cuff blood pressure <140/90mmHg at the end of 6 weeks treatment

Secondary outcome: 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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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 ACE

inhibitors or alpha- or beta-blocker therapy, subject has Type 1 or Type 2 diabetes

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Starting date: March 2008
Last updated: June 2, 2008