Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00553969
Other study ID # 0709M15829
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received November 5, 2007
Last updated March 23, 2018
Start date November 2007
Est. completion date December 2010

Study information

Verified date March 2018
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date December 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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
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
placebo and placebo
capsule once daily for 9 months; dosage unknown

Locations

Country Name City State
United States University of Minnesota, Variety Club Research Center 102 Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Disease Score (DS) Among the Treatment Groups 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. Baseline and nine months
See also
  Status Clinical Trial Phase
Completed NCT03313284 - Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects? N/A
Completed NCT01741779 - Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function N/A
Withdrawn NCT01074918 - Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients Phase 1/Phase 2
Completed NCT00288158 - Primary Prevention of Hypertension in Obese Adolescents Phase 2
Completed NCT01190319 - Study: Effects of Strawberries on Blood Pressure N/A
Completed NCT01008176 - Restoring Sleep Homeostasis to Lower Blood Pressure N/A
Unknown status NCT02197910 - Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects N/A
Recruiting NCT04543656 - Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence N/A
Completed NCT03168789 - Tension Tamer Randomized Control Trial N/A
Completed NCT00170937 - A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome Phase 4
Completed NCT01741766 - The Effects of Stretching Training on Arterial Function and Autonomic Control N/A
Completed NCT02143817 - Whole Body Vibration Combined With L-citrulline Supplementation on Cardiovascular Function and Body Composition N/A
Terminated NCT00388388 - Losartan Versus Hydrochlorothiazide in Reversing Remodeling of Small Arteries in Pre-Hypertensive Pre-Diabetic Subjects Phase 2
Completed NCT02148458 - Short Term Intermittent Fasting and Mediterranean Diet N/A
Terminated NCT01349114 - Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects Phase 4
Completed NCT02038179 - Center of Research Translation (CORT) Project 2 Phase 2/Phase 3
Completed NCT00970931 - Hypertension Prevention in Pre-Hypertensive Individuals Phase 3
Completed NCT01202175 - Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension Phase 4
Not yet recruiting NCT01364675 - Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects N/A
Completed NCT01841840 - The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke N/A