Pharmacodynamic Equivalence of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular (CV) Polypill Acetylsalicylic Acid-Atorvastatin-Ramipril (AAR) as Compared to Monotherapy

Status unconfirmed · Phase 2

Conditions studied: Hypertension

In brief

This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg.

Key facts

Study ID

NCT02791958

Run by

Ferrer Internacional S.A.

People needed

528

Starts

2016-03-01

Expected to finish

2017-10-01

Last updated by the study team

2017-04-10

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients aged ≥18 and <75 years.
• Patients with Stage 1 (SBP/DBP: 140-159/90-99 mmHg) or Stage 2 (SBP/DBP: ≥160/≥100 mmHg) hypertension, either untreated or after a wash out period.
• Patients with an LDL cholesterol level of ≥100 mg/dL and, either untreated or after the wash out period.
• Patients untreated with BP lowering and / or lipid lowering medication
• Patients treated with BP lowering and / or lipid lowering medication can be included if the medication can be safely withdrawn as per physician's judgment.
• Provide written informed consent.

You may not qualify if…

• Patients with a BMI of > 35
• SBP < 140 mmHg and DBP < 90 mmHg
• Severe hypertension defined as SBP > 180 mmHg and Diastolic Blood Pressure (DBP) > 110 mmHg
• LDL cholesterol level of <100 mg/dL, either untreated or after the wash out period.
• Serum triglyceride concentration ≥400 mg/dL, either untreated or after the wash out period.
• Patients with a medical condition requiring the chronic pharmacological treatments listed below:
• Cytochrome P450 3A4 (CYP3A4) inhibitors (eg itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone).
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• K-sparing diuretics.
• Lithium.
• Amiodarone and verapamil.
• Oral anticoagulants (eg, warfarin).
• Steroids.
• Digoxin.
• Gemfibrozil.
• Niacin.
• Potassium supplements.
• Cyclosporine.
• Danazol.
• Rifampicin.
• Evidence of any known clinically significant chronic disease
• Patients with renal impairment with Creatinine Clearance (CrCl) < 40 mL/ min/ 1.73 m2
• Creatine phosphokinase (CPK) ≥5 x the upper limit of normal (ULN).
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN.
• Total bilirubin ≥1.5 x ULN

Where it is running

• Central Alabama Research — Birmingham, Alabama, United States
• National Research Institute — Los Angeles, California, United States
• Clinical Trials Research — Sacramento, California, United States
• Clinical Trials Investigators, Inc — Tustin, California, United States
• Infoshpere Clinical Research, Inc — West Hills, California, United States
• Meridien Research — Bradenton, Florida, United States
• PAB Clinical Research — Brandon, Florida, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Clinical Therapeutics Corporation — Coral Gables, Florida, United States
• Moonshine Research Center, Inc — Doral, Florida, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Nova Clinical Research Center inc — Hialeah, Florida, United States
• Dr. John C. Gutleber Weight Loss, Beauty, and Family Practice — Homestead, Florida, United States
• Westside Center for Clinical Research — Jacksonville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Health Awareness, Inc. — Jupitor, Florida, United States
• The Chappel Group Research — Kissimmee, Florida, United States
• Sunrise Medical Center — Lauderdale Lakes, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• Louisville Metabolic and Atherosclerosis Research — Louisville, Kentucky, United States
• Clinical Trials of America LA, LLC — Monroe, Louisiana, United States
• DelRicht Research — New Orleans, Louisiana, United States
• Bay State Clinical Trials, Inc — Watertown, Massachusetts, United States

Full record on ClinicalTrials.gov

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