Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pre-Hypertension	Drug: carvedilol phosphate Drug: lisinopril Drug: carvedilol phosphate and lisinopril	Phase I Phase II

MedlinePlus related topics:

High Blood Pressure

ChemIDplus related topics:

Lisinopril Carvedilol Carvedilol phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment

Official Title:	Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease. DETECT (DEtection and Treatment of Early Cardiovascular Disease Trial)

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

The overall Rasmussen Disease Score (RDS) change from baseline to 9 months will be the primary end-point. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quantitative change in each of the RDS components from baseline to 9 months will serve as a secondary end-point. The 3-month data will provide early evidence for drug efficacy and will be analyzed similarly as a secondary end-point. [ Time Frame: 3-9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Coreg CR + lisinopril	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
2: Experimental Coreg CR + placebo	Drug: carvedilol phosphate Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months
3: Experimental lisinopril + placebo	Drug: lisinopril tablets, 10mg once daily for 1 month, 20mg once daily for 8 months

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553969

Contacts


Contact: Sara M Saul, PhD	612-626-5446	saul@umn.edu

Locations


United States, Minnesota
	University of Minnesota, Variety Club Research Center 102	Recruiting
	Minneapolis, Minnesota, United States, 55455
	Contact: Sara M Saul, PhD 612-626-5446 saul@umn.edu

Sponsors and Collaborators

University of Minnesota

GlaxoSmithKline

Investigators


Principal Investigator:	Jay N Cohn, MD	Professor, University of Minnesota, Cardiology Division

More Information

Responsible Party:	University of Minnesota ( Jay N. Cohn, MD )
Study ID Numbers:	0709M15829
First Received:	November 5, 2007
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00553969
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

cardiovascular disease prevention

Study placed in the following topic categories:

Lisinopril

Vascular Diseases

Carvedilol

Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents

Vasodilator Agents

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Cardiotonic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Cardiovascular Agents

Adrenergic alpha-Antagonists

Antihypertensive Agents

Protective Agents

Pharmacologic Actions

Protease Inhibitors

Therapeutic Uses

Angiotensin-Converting Enzyme Inhibitors

Adrenergic beta-Antagonists

Cardiovascular Diseases

Adrenergic Antagonists

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	University of Minnesota GlaxoSmithKline
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00553969