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...
Date First Received: February 14, 2008
Last Updated: June 2, 2008
Verified by: GlaxoSmithKline, June 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2008
Overall Status: Active, not recruiting
Estimated Enrollment: 348
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: carvedilol controlled release/lisinopril
Outcome Measures for this Clinical Trial
Primary Measures
- proportion of subjects with mean sitting cuff blood pressure <140/90mmHg at the end of 6 weeks treatment
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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.
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK GSK, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00624065
Study ID Number: COR111096
ClinicalTrials.gov Identifier: NCT00624065
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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