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Sponsored by: |
InVasc Therapeutics, Inc. |
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Information provided by: | InVasc Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00795262 |
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 |
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Diabetes Hypertension |
Drug: Quinapril (Accupril) plus Alpha Lipoic Acid Drug: Quinapril (Accupril) plus Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participant will receive Quinapril 40 mg (Accupril) with alpha lipoic acid (ALA)for 8 weeks.
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Drug: Quinapril (Accupril) plus Alpha Lipoic Acid
Patients in Arm 1 (n=20) will receive quinapril 40 mg and Alpha Lipoic Acid (600 mg/day)for an 8-week treatment period (Treatment A). There will a "wash-out period" of 4 weeks between the cross over.
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2: Placebo Comparator
Quinapril 40 mg (Accupril)plus placebo will be given for 8 weeks.
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Drug: Quinapril (Accupril) plus Placebo
Quinapril 40 mg daily with placebo for 8 weeks. Each participant will have a "washout" period between arms for 4 weeks.
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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.
Contact: Ibis E. Bridges | 404-296-1130 | ibis.bridges@metroatlantaresearch.com |
Contact: Michelle B. Warren | 404-296-1130 | michelle.binns@metroatlantaresearch.com |
United States, Georgia | |
Atlanta Vascular Research Foundation | Recruiting |
Tucker, Georgia, United States, 30084 | |
Contact: Ibis Bridges 404-296-1130 ibis.bridges@metroatlantaresearch.com | |
Contact: Michelle B Warren 404-296-1130 michelle.binns@metroatlantaresearch.com | |
Principal Investigator: Syed T. Rahman, MD |
Principal Investigator: | Syed T. Rahman, MD | Atlanta Vascular Research Foundation |
Responsible Party: | Atlanta Vascular Research Foundation ( Syed T. Rahman, MD ) |
Study ID Numbers: | INV-064 QUALITY |
Study First Received: | November 20, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00795262 |
Health Authority: | United States: Institutional Review Board |
brachial artery reactivity |
Quinapril Metabolic Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Thioctic Acid Hypertension |
Vitamin B Complex Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents |
Protective Agents Pharmacologic Actions Protease Inhibitors Therapeutic Uses Vitamins Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Micronutrients |