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

Sponsored by:	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 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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

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:

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

Secondary Outcome 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

Estimated Enrollment:	348
Study Start Date:	March 2008

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 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, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	COR111096
Study First Received:	February 14, 2008
Last Updated:	October 16, 2008
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

Study placed in the following topic categories:

Essential Hypertension
Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Lisinopril
Vascular Diseases
Cardiovascular Agents
Adrenergic alpha-Antagonists

Antihypertensive Agents
Protease Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Hypertension
Carvedilol

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 July 02, 2009