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	Drug: lisinopril + placebo Drug: carvedilol controlled release/lisinopril	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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 ]

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 ]

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
carvedilol CR + lisinopril: Experimental	Drug: carvedilol controlled release/lisinopril carvedilol CR + lisinopril given as separate pills
lisinopril + placebo: Active Comparator	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.

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 75 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	COR111096
Study First Received:	February 14, 2008
Results First Received:	June 11, 2009
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00624065 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

hypertension
COREG CR
lisinopril
target blood pressure
carvedilol CR

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Lisinopril
Physiological Effects of Drugs
Vascular Diseases
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Cardiovascular Agents

Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Hypertension
Carvedilol

ClinicalTrials.gov processed this record on November 27, 2009