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

Not Applicable

Completed

• Conditions: Diabetes; Hypertension
• Interventions: Drug: accupril, placebo; Drug: Quinapril (Accupril) plus Alpha Lipoic Acid; Drug: accupril, alpha lipoic acid

• Registration Number: NCT00795262
• Lead Sponsor: InVasc Therapeutics, Inc.

Brief Summary

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.

Detailed Description

The participant will be randomized to either quinapril 40 mg and alpha lipoic acid versus quinapril 40 mg and placebo for 8 weeks. There will be a wash out period of 4 weeks between the cross over. The participant will be assigned the cross over for 8 weeks on the opposite therapy.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-04
• Last Update Posted: 2011-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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.

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Exclusion Criteria

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

1. Abstinence, meaning a total lack of any sexual activity.
2. Oral contraceptives (the "pill"),
3. Contraceptive injections,
4. Intrauterine device,
5. Double-barrier method (diaphragm or condom + spermicidal cream),
6. Contraceptive patch, or
7. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo comparator	accupril, placebo	Quinapril 40 mg (Accupril)plus placebo will be given for 8 weeks.
Active comparator	Quinapril (Accupril) plus Alpha Lipoic Acid	Quinapril 40 mg plus Alpha Lipoic Acid (ALA)on vascular effects of patients with diabetes and hypertension
Active comparator	accupril, alpha lipoic acid	Quinapril 40 mg plus Alpha Lipoic Acid (ALA)on vascular effects of patients with diabetes and hypertension

Primary Outcome Measures

Name	Time	Method
Comparison of relative change of systolic BP/diastolic BP and urinary albumin excretion from baseline in diabetic patients treated with quinapril plus lipoic acid versus quinapril and placebo.	The total study period is 22 weeks i.e. the initial prescreening visit followed 1 week later by the baseline study visit, 8 weeks of treatment (Treatment A or B), 4 weeks washout, 8 weeks of treatment (Treatment A or B).

Secondary Outcome Measures

Name	Time	Method
Comparison of patients treated with quinapril plus lipoic acid versus quinapril plus placebo in the following areas: a) Changes from baseline in high sensitivity C-reactive protein, adiponectin, and leptin	at baseline (week-1), weeks 8, 12 and 20.

Trial Locations

Locations (1)

Atlanta Vascular Research Foundation; 🇺🇸 Tucker, Georgia, United States