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

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Collaborator:	GlaxoSmithKline
Information provided by (Responsible Party):	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00553969

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Carvedilol Lisinopril Carvedilol phosphate

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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 ]

Enrollment:	100
Study Start Date:	November 2007
Study Completion Date:	December 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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

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

Locations

United States, Minnesota
University of Minnesota, Variety Club Research Center 102
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

GlaxoSmithKline

Investigators

Principal Investigator:

Jay N Cohn, MD

Professor, University of Minnesota, Cardiology Division

More Information

No publications provided

Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00553969 History of Changes
Other Study ID Numbers:	0709M15829
Study First Received:	November 5, 2007
Last Updated:	February 3, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

cardiovascular disease prevention

Additional relevant MeSH terms:

Cardiovascular Diseases
Hypertension
Prehypertension
Vascular Diseases
Carvedilol
Lisinopril
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012