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

NCT ID: NCT00553969

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-12-31

Brief 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.

Detailed Description

• This study will compare the effect of Coreg CR and lisinopril, separately and together, on Rasmussen Disease Score in a controlled study with an inactive substance (placebo).
• Study patients will have pre-hypertensive (slightly elevated) blood pressures not requiring therapy.
• Lisinopril is an angiotensin converting enzyme (ACE) inhibitor. Angiotensin is a chemical that is made by the body continuously. Angiotensin narrows blood vessels and thereby maintains (elevates) blood pressure. When the enzyme is blocked by lisinopril, angiotensin cannot be converted into its active form. As a result, blood pressure is lowered. Lisinopril is a drug that has been approved for use by the U.S. Food and Drug Administration (FDA) and health authorities for the treatment of high blood pressure and heart failure.
• Coreg CR is a once-a-day heart medication that is part of a class of drugs known as beta-blockers. Beta-blockers prevent beta-adrenergic substances such as adrenaline from activating parts of the nervous system, including the heart. Beta-blockers therefore relieve stress on the heart by slowing heart beat, decreasing the force of heart muscle contractions, and reducing blood pressure. Coreg has also been approved by the FDA for the treatment of hypertension and various other cardiovascular conditions.
• It is possible that the beta blocker could increase the benefits of the ACE inhibitor by inhibiting renin production, which is an important step in angiotensin production. These two drugs may act together to provide even more protection to blood vessels and the heart.

Conditions

Pre-hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Coreg CR + lisinopril

Group Type: EXPERIMENTAL

carvedilol phosphate and lisinopril

Intervention Type: DRUG

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

2

Coreg CR + placebo

Group Type: EXPERIMENTAL

carvedilol phosphate

Intervention Type: DRUG

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

3

lisinopril + placebo

Group Type: EXPERIMENTAL

lisinopril

Intervention Type: DRUG

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

4

placebo + placebo

Group Type: PLACEBO_COMPARATOR

placebo and placebo

Intervention Type: DRUG

capsule once daily for 9 months; dosage unknown

Interventions

carvedilol phosphate

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

Intervention Type: DRUG

lisinopril

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

Intervention Type: 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

Intervention Type: DRUG

placebo and placebo

capsule once daily for 9 months; dosage unknown

Intervention Type: DRUG

Other Intervention Names

Coreg CR; Coreg CR (carvedilol phosphate)

Eligibility Criteria

Inclusion Criteria

• Males and females > 18 years old with pre-hypertensive or borderline blood pressures (systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg) deemed not to need antihypertensive therapy. Subjects must also have one additional risk factor for cardiovascular disease, including:
• LDL > 130 and < 160 mg/dL
• HDL < 40 mg/dL
• Fasting blood sugar >100 and < 126 mg/dL
• Body mass index ≥ 30
• Smoker
• Family history of premature heart disease or hypertension

Exclusion Criteria

• Patients with a history of cardiac, cerebral or other vascular events within the previous 6 months will be excluded. Other exclusions include background therapy with a beta blocker or ACE inhibitor therapy, known or suspected intolerance to beta blockers or ACE inhibitors, angiotensin receptor blocker therapy, or diabetes. Pregnant or lactating women, and women of child-bearing age who are not using an acceptable form of contraception are also excluded from this study.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay N Cohn, MD

Role: PRINCIPAL_INVESTIGATOR

Professor, University of Minnesota, Cardiology Division

Locations

University of Minnesota, Variety Club Research Center 102

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0709M15829

Identifier Type: -

Identifier Source: org_study_id