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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795262
First Posted: November 21, 2008
Last Update Posted: May 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
InVasc Therapeutics, Inc.
November 20, 2008
November 21, 2008
May 5, 2011
July 2008
July 2009   (Final data collection date for primary outcome measure)
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). ]
Same as current
Complete list of historical versions of study NCT00795262 on ClinicalTrials.gov Archive Site
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. ]
Same as current
Not Provided
Not Provided
 
Effects of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Diabetes and Hypertension
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
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes
  • Hypertension
  • Drug: Quinapril (Accupril) plus Alpha Lipoic Acid
    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
  • Drug: accupril, placebo
    accupril 40 mg
    Other Names:
    • Accupril
    • quinapril
  • Drug: accupril, alpha lipoic acid
    accupril (quinapril) 40 mg plus alpha lipoic acid 600 mg
    Other Names:
    • quinapril
    • accupril
    • ALA
    • alpha lipoic acid
    • lipoic acid
  • Placebo Comparator: placebo comparator
    Quinapril 40 mg (Accupril)plus placebo will be given for 8 weeks.
    Intervention: Drug: accupril, placebo
  • Active Comparator: Active comparator
    Quinapril 40 mg plus Alpha Lipoic Acid (ALA)on vascular effects of patients with diabetes and hypertension
    Interventions:
    • Drug: Quinapril (Accupril) plus Alpha Lipoic Acid
    • Drug: accupril, alpha lipoic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
July 2009
July 2009   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00795262
INV-064 QUALITY
Yes
Not Provided
Not Provided
Syed T. Rahman, MD, Atlanta Vascular Research Foundation
InVasc Therapeutics, Inc.
Not Provided
Principal Investigator: Syed T. Rahman, MD Atlanta Vascular Research Foundation
InVasc Therapeutics, Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP