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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00624065

Purpose

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.

Condition	Intervention	Phase
Stage 1 or 2 Essential Hypertension Hypertension	Drug: carvedilol controlled release/lisinopril Drug: lisinopril + placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Carvedilol Lisinopril

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]
Mean change was calculated as Week 6 values minus Baseline values.

Enrollment:	348
Study Start Date:	March 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: carvedilol CR + lisinopril	Drug: carvedilol controlled release/lisinopril carvedilol CR + lisinopril given as separate pills Other Name: carvedilol controlled release/lisinopril
Active Comparator: lisinopril + placebo	Drug: lisinopril + placebo lisinopril plus placebo to match carvedilol CR

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 </=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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624065

Show 74 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00624065 History of Changes
Other Study ID Numbers:	COR111096
Study First Received:	February 14, 2008
Results First Received:	June 11, 2009
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

target blood pressure
hypertension
COREG CR
carvedilol CR
lisinopril

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Lisinopril
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012