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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00553969
First received: November 5, 2007
Last updated: February 17, 2017
Last verified: February 2017
  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 Drug: placebo and placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Participant, Care Provider, 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:


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 ]
  • Change in Disease Score (DS) Among the Treatment Groups [ Time Frame: Baseline and nine months ]
    Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble.


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 ]

Enrollment: 101
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
Placebo Comparator: 4
placebo + placebo
Drug: placebo and placebo
capsule once daily for 9 months; dosage unknown

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: December 16, 2013
Last Updated: February 17, 2017

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Prehypertension
Vascular Diseases
Carvedilol
Lisinopril
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
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 July 19, 2017