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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

November 5, 2007
February 17, 2017
November 2007
September 2010   (Final data collection date for primary outcome measure)
  • 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.
The Overall Rasmussen Disease Score (RDS) Change From Baseline to 9 Months Will be the Primary End-point. [ Time Frame: 9 months ]
Complete list of historical versions of study NCT00553969 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease
Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease. DETECT (DEtection and Treatment of Early Cardiovascular Disease Trial)
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.
  • 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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Pre-hypertension
  • Drug: carvedilol phosphate
    Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months
    Other Name: Coreg CR
  • 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
    Other Name: Coreg CR (carvedilol phosphate)
  • Drug: placebo and placebo
    capsule once daily for 9 months; dosage unknown
  • Experimental: 1
    Coreg CR + lisinopril
    Intervention: Drug: carvedilol phosphate and lisinopril
  • Experimental: 2
    Coreg CR + placebo
    Intervention: Drug: carvedilol phosphate
  • Experimental: 3
    lisinopril + placebo
    Intervention: Drug: lisinopril
  • Placebo Comparator: 4
    placebo + placebo
    Intervention: Drug: placebo and placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2010
September 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00553969
0709M15829
No
Not Provided
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University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
GlaxoSmithKline
Principal Investigator: Jay N Cohn, MD Professor, University of Minnesota, Cardiology Division
University of Minnesota - Clinical and Translational Science Institute
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP