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

This study has been completed.
Sponsor:
Information provided by:
InVasc Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00795262
First received: November 20, 2008
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Diabetes
Hypertension
Drug: Quinapril (Accupril) plus Alpha Lipoic Acid
Drug: accupril, placebo
Drug: accupril, alpha lipoic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Hypertension

Resource links provided by NLM:


Further study details as provided by InVasc Therapeutics, Inc.:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo comparator
Quinapril 40 mg (Accupril)plus placebo will be given for 8 weeks.
Drug: accupril, placebo
accupril 40 mg
Other Names:
  • Accupril
  • quinapril
Active Comparator: Active comparator
Quinapril 40 mg plus Alpha Lipoic Acid (ALA)on vascular effects of patients with diabetes and 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, alpha lipoic acid
accupril (quinapril) 40 mg plus alpha lipoic acid 600 mg
Other Names:
  • quinapril
  • accupril
  • ALA
  • alpha lipoic acid
  • lipoic acid

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795262

Locations
United States, Georgia
Atlanta Vascular Research Foundation
Tucker, Georgia, United States, 30084
Sponsors and Collaborators
InVasc Therapeutics, Inc.
Investigators
Principal Investigator: Syed T. Rahman, MD Atlanta Vascular Research Foundation
  More Information

No publications provided

Responsible Party: Syed T. Rahman, MD, Atlanta Vascular Research Foundation
ClinicalTrials.gov Identifier: NCT00795262     History of Changes
Other Study ID Numbers: INV-064 QUALITY
Study First Received: November 20, 2008
Last Updated: May 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by InVasc Therapeutics, Inc.:
brachial artery reactivity

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Thioctic Acid
Quinapril
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014