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

NCT00795262 | Completed DMC

• 1 other identifier: INV-064 QUALITY
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension

Keywords

brachial artery reactivity

Outcome Measures

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.

  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

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

Study Arms (2)

placebo comparator

PLACEBO COMPARATOR

Quinapril 40 mg (Accupril)plus placebo will be given for 8 weeks.

Drug: accupril, placebo

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; Drug: accupril, alpha lipoic acid

Interventions

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).

Also known as: ALA, Alpha Lipoic Acid, Quinapril, Accupril

Active comparator

accupril, placebo DRUG

accupril 40 mg

Also known as: Accupril, quinapril

placebo comparator

accupril, alpha lipoic acid DRUG

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

Also known as: quinapril, accupril, ALA, alpha lipoic acid, lipoic acid

Active comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InVasc Therapeutics, Inc.: lead

Study Sites (1)

Atlanta Vascular Research Foundation

Tucker, Georgia, 30084, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Interventions

Quinapril; Thioctic Acid

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Syed T. Rahman, MD

  Atlanta Vascular Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 5, 2011

Record last verified: 2011-05

Locations

US (1)