Skip to main content
OpenTrials
Completed

NCT Number: NCT00795262

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Vascular Research Foundation

Tucker, Georgia, 30084, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

  • 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.

Treatment and study plan

Quinapril (Accupril) plus Alpha Lipoic Acid

Drug

Patients in Arm 2 (n=20) will receive quinapril 40 mg and Alpha Lipoic Acid (600 mg/day)for an 8-week treatment period (Treatment A).

Other names: ALA, Alpha Lipoic Acid, Quinapril, Accupril

accupril, placebo

Drug

accupril 40 mg

Other names: Accupril, quinapril

accupril, alpha lipoic acid

Drug

accupril (quinapril) 40 mg plus alpha lipoic acid 600 mg

Other names: quinapril, accupril, ALA, alpha lipoic acid, lipoic acid

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. 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

    Time frame: at baseline (week-1), weeks 8, 12 and 20.

Sponsors and collaborators

Lead sponsor

InVasc Therapeutics, Inc.

Industry

Registry information

Official study title

A 22-week Randomized, Cross-over Study Comparing the Effects of Quinapril and Quinapril Plus Alpha-lipoic Acid (ALA) on Patients With Diabetes Mellitus and Hypertension

Acronym: QUALITY

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 21, 2008
Registry last updated
May 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.