Effects of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Diabetes and Hypertension

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetes, Hypertension

In brief

We will evaluate the combination of quinapril and alpha lipoic acid in patients with diabetes mellitus and hypertension. We will determine whether the combination of quinapril and lipoic acid as compared to quinapril and placebo provides benefit on systemic blood pressure and proteinuria.

Key facts

Study ID

NCT00795262

Run by

InVasc Therapeutics, Inc.

People needed

23

Starts

2008-07-01

Expected to finish

2009-07-01

Last updated by the study team

2011-05-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have a diagnosis of diabetes mellitus as defined by fasting blood glucose levels greater than ot equal to 126mg/dL and a systolic BP greater than 125 mm Hg at the time of screening will be included in the study. Patients may be on antihypertensive medication but not on ACE inhibitor or ARB therapy at the time of enrollment.

You may not qualify if…

• Systolic blood pressure > 180 mmHg Creatinine > 2.5 mg/dl Glycosylated hemoglobin > 7.5% Congestive heart failure (NYHA Class II, III or IV) Coronary angiography planned prior to baseline sampling Chronic autoimmune disease Chronic inflammatory disease or known cancer in evolution life expectancy < 1 year Immunosuppressives or treatment with any other investigational drug within the last 30 days Pregnant or nursing women Participants who experience any side effects to quinapril and/or alpha lipoic acid
• Women of childbearing potential Women of childbearing potential enrolled in the study should use one of the acceptable methods of birth control as listed below
• Abstinence, meaning a total lack of any sexual activity.
• Oral contraceptives (the "pill"),
• Contraceptive injections,
• Intrauterine device,
• Double-barrier method (diaphragm or condom + spermicidal cream),
• Contraceptive patch, or
• Male partner sterilization.
• Pregnancy Any pregnancy that occurs during study participation must be reported to the Principal Investigator and the study coordinator at the earliest. The pregnancy must be followed up to determine outcome and status of the mother and child. To ensure subject safety, any subject that becomes pregnant during the study will be discontinued from the trial.

Where it is running

• Atlanta Vascular Research Foundation — Tucker, Georgia, United States

Full record on ClinicalTrials.gov

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