Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease (DETECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00553969|
Recruitment Status : Completed
First Posted : November 6, 2007
Results First Posted : December 17, 2014
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pre-hypertension||Drug: carvedilol phosphate Drug: lisinopril Drug: carvedilol phosphate and lisinopril Drug: placebo and placebo||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||December 2010|
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)
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
lisinopril + placebo
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
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553969
|United States, Minnesota|
|University of Minnesota, Variety Club Research Center 102|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Jay N Cohn, MD||Professor, University of Minnesota, Cardiology Division|