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

NCT ID: NCT00624065

Last Updated: 2016-12-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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target blood pressure hypertension COREG CR carvedilol CR Stage 1 or 2 essential hypertension lisinopril

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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carvedilol CR + lisinopril

Group Type EXPERIMENTAL

carvedilol controlled release/lisinopril

Intervention Type DRUG

carvedilol CR + lisinopril given as separate pills

lisinopril + placebo

Group Type ACTIVE_COMPARATOR

lisinopril + placebo

Intervention Type DRUG

lisinopril plus placebo to match carvedilol CR

Interventions

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carvedilol controlled release/lisinopril

carvedilol CR + lisinopril given as separate pills

Intervention Type DRUG

lisinopril + placebo

lisinopril plus placebo to match carvedilol CR

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mobile, Alabama, United States

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Chandler, Arizona, United States

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Glendale, Arizona, United States

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Goodyear, Arizona, United States

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Litchifield Park/Arizona, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Beuna Park, California, United States

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Fountain Valley, California, United States

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Poway, California, United States

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San Ramon, California, United States

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Tustin, California, United States

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Vista, California, United States

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Coral Gables, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Tamarac, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Nampa, Idaho, United States

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Aurora, Illinois, United States

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Chicago, Illinois, United States

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Gillespie, Illinois, United States

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Elkhart, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Paducah, Kentucky, United States

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Slidell, Louisiana, United States

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Columbia, Maryland, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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Buffalo, New York, United States

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East Syracuse, New York, United States

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New York, New York, United States

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Westfield, New York, United States

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Raleigh, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Corvallis, Oregon, United States

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Altoona, Pennsylvania, United States

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Havertown, Pennsylvania, United States

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Jersey Shore, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Columbia, South Carolina, United States

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Manning, South Carolina, United States

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Johnson City, Tennessee, United States

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Austin, Texas, United States

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Georgetown, Texas, United States

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Grand Prairie, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Draper, Utah, United States

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Magna, Utah, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Sandy City, Utah, United States

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Bellingham/Washington, Washington, United States

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Gig Harbor, Washington, United States

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Olympia, Washington, United States

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Tacoma, Washington, United States

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Beloit, Wisconsin, United States

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Countries

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United States

References

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GSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion.

Reference Type BACKGROUND

Study Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Dataset Specification

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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COR111096

Identifier Type: -

Identifier Source: org_study_id