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Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease

NCT00553969 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2018-04-24

Study results available
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Summary

This study will examine the individual and combined effects of Coreg CR and lisinopril, on cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo controlled comparison over a 9-month study period. Patients to be randomized will have pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least one additional cardiovascular risk factor.

Conditions

  • Pre-hypertension

Interventions

DRUG

carvedilol phosphate

Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months

DRUG

lisinopril

tablets, 10mg once daily for 1 month, 20mg once daily for 8 months

DRUG

carvedilol phosphate and lisinopril

carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months

DRUG

placebo and placebo

capsule once daily for 9 months; dosage unknown

Sponsors & Collaborators

Principal Investigators

  • Jay N Cohn, MD · Professor, University of Minnesota, Cardiology Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00553969 on ClinicalTrials.gov