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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR QUINAPRIL HYDROCHLORIDE

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Clinical Trials for Quinapril Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00065559 Treatment of Diabetic Nephropathy Terminated National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A COX-2 is an enzyme that is found in several different tissues in the body. COX-2 appears to produce a substance called prostaglandins, mainly at sites of inflammation. Several drugs have been approved by the FDA that inhibit COX-2 such as celecoxib, or brand name Celebrex®. These drugs are primarily used in patients with osteoarthritis and rheumatoid arthritis to decrease inflammation and pain. COX-2 inhibitors have been developed because they are more selective in treatment of inflammation and pain and tend to have fewer gastrointestinal side effects than NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen, naproxen, etc. The normal adult kidney expresses COX-2 in various regions. Prostaglandins, which are produced in the kidney by COX-2, may contribute to glomerular and tubulointerstitial inflammatory diseases (types of kidney diseases due to inflammation). In some animal studies, COX-2 inhibitors have been shown to be potentially beneficial in reducing the amount of protein spilled in the urine and preserving kidney function with these inflammatory kidney diseases. This study will compare the effects of COX-2 inhibitor to placebo (an inactive substance) in patients with diabetic nephropathy (kidney disease due to diabetes) and proteinuria (spilling protein in the urine) on 24-hour urinary protein excretion. This study is designed to see whether COX-2 inhibitors are useful in treating diabetic patients with kidney disease. The purpose of this study is a short-term pilot study that will allow the gathering of important data such as the ability to carry out the study and carry it out safely. Subjects with proteinuria and diabetic kidney disease already on ACE (Angiotensin-Converting Enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) therapy (types of blood pressure medicines) will be randomized to a type of study in which each subject will serve as their own control. The study is set up so that each subject will receive either the COX-2 inhibitor or placebo for a period followed by a period of no drug and then followed by a period of receiving either the COX-2 inhibitor or placebo (whichever they did not receive the first period).
NCT00147524 Non-Comparative Study To Evaluate Changes In FMD After Quinapril Therapy In Hypertensive Women Completed Pfizer Phase 4 ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an effective and well-tolerated ACE-I for the treatment of patients with hypertension and congestive heart failure. Quinapril produces favourable haemodynamic changes and improves ventricular and endothelial function in patients with various cardiovascular disorders. These effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE. Quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved FMD or reduced vasoconstrictive/increased vasodilative response to Ach) in patients with CAD and hypertension over 2 to 6 months of therapy; improved endothelial function was also observed in patients with CHF receiving a single infusion of quinaprilat. In general, quinapril showed neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) There are no data available considering effects of quinapril on endothelial dysfunction in post- menopausal woman with mild to moderate hypertension and with pathological endothelial function.
NCT00150826 QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 4 INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin converting enzyme) inhibition (quinapril) in improving coronary microvascular function. PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow reserve limitations and evidence for myocardial ischemia in the absence of significant coronary artery stenosis. STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific variables, and site by treatment effects. SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle Angina Questionnaire adjusting for baseline values, site, and site by treatment effects. SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and occurrence of adverse events. STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the study has been provided. Interim analyses are planned after 15 patients have been enrolled in each group. ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT EACH SITE Approximately 26
NCT00150826 QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia Completed University of Florida Phase 4 INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin converting enzyme) inhibition (quinapril) in improving coronary microvascular function. PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow reserve limitations and evidence for myocardial ischemia in the absence of significant coronary artery stenosis. STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific variables, and site by treatment effects. SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle Angina Questionnaire adjusting for baseline values, site, and site by treatment effects. SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and occurrence of adverse events. STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the study has been provided. Interim analyses are planned after 15 patients have been enrolled in each group. ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT EACH SITE Approximately 26
NCT00154050 High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty Completed Technische Universität Dresden N/A The study is designed to test the hypothesis that high dose candesartan treatment compared to quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent angioplasty in peripheral occlusive artery disease.
NCT00159692 Amlodipine Diabetic Hypertension Efficacy Response Trial Completed Pfizer Phase 4 To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure goal of <130/80 with amlodipine versus placebo in subjects initially treated with quinapril or losartan.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Quinapril Hydrochloride

Condition Name

Condition Name for Quinapril Hydrochloride
Intervention Trials
Hypertension 10
Healthy 6
Metabolic Syndrome X 1
Arterial Occlusive Diseases 1
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Condition MeSH

Condition MeSH for Quinapril Hydrochloride
Intervention Trials
Hypertension 8
Diabetes Mellitus 4
Coronary Artery Disease 2
Kidney Diseases 2
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Clinical Trial Locations for Quinapril Hydrochloride

Trials by Country

Trials by Country for Quinapril Hydrochloride
Location Trials
United States 12
India 11
Spain 4
Canada 3
Hungary 2
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Trials by US State

Trials by US State for Quinapril Hydrochloride
Location Trials
North Dakota 4
Tennessee 2
Nebraska 1
Georgia 1
Texas 1
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Clinical Trial Progress for Quinapril Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Quinapril Hydrochloride
Clinical Trial Phase Trials
Phase 4 15
Phase 3 1
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Quinapril Hydrochloride
Clinical Trial Phase Trials
Completed 19
Terminated 2
Unknown status 2
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Clinical Trial Sponsors for Quinapril Hydrochloride

Sponsor Name

Sponsor Name for Quinapril Hydrochloride
Sponsor Trials
Pfizer 7
Mylan Pharmaceuticals 4
University of Vigo 2
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Sponsor Type

Sponsor Type for Quinapril Hydrochloride
Sponsor Trials
Other 22
Industry 17
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Teva
Daiichi Sankyo
US Army
Accenture
Baxter
Deloitte
Express Scripts
Argus Health

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