Comparison of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Patients With Diabetes Mellitus (DM) and Hypertension (HTN)
Information source: InVasc Therapeutics, Inc.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Hypertension
Intervention: Quinapril (Accupril) plus Alpha Lipoic Acid (Drug); Quinapril (Accupril) plus Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: InVasc Therapeutics, Inc. Official(s) and/or principal investigator(s):
Syed T. Rahman, MD, Principal Investigator, Affiliation: Atlanta Vascular Research Foundation
Overall contact:
Ibis E. Bridges, Phone: 404-296-1130, Email: ibis.bridges@metroatlantaresearch.com
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.
Clinical Details
Official 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment
Primary outcome: 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.
Secondary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
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.
Locations and Contacts
Ibis E. Bridges, Phone: 404-296-1130, Email: ibis.bridges@metroatlantaresearch.com
Atlanta Vascular Research Foundation, Tucker, Georgia 30084, United States; Recruiting
Ibis Bridges, Phone: 404-296-1130, Email: ibis.bridges@metroatlantaresearch.com
Michelle B Warren, Phone: 404-296-1130, Email: michelle.binns@metroatlantaresearch.com
Syed T. Rahman, MD, Principal Investigator
Additional Information
Starting date: July 2008
Ending date: December 2009
Last updated: November 20, 2008
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