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
NCT ID: NCT02791958
Last Updated: 2017-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
528 participants
INTERVENTIONAL
2016-03-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CV Fixed Dose Combination Pill AAR
Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg).
Cardiovascular Fixed Dose Combination Pill AAR
A once daily oral dose of the Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) for 4 weeks.
Atorvastatin
Atorvastatin 40 mg (Lipitor®).
Atorvastatin 40 mg
A once daily oral dose of atorvastatin 40 mg (Lipitor®) for 4 weeks
Ramipril
Ramipril 10 mg (Altace®).
Ramipril 10 mg
A once daily oral dose of ramipril 10 mg (Altace®) for 4 weeks
Interventions
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Cardiovascular Fixed Dose Combination Pill AAR
A once daily oral dose of the Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) for 4 weeks.
Atorvastatin 40 mg
A once daily oral dose of atorvastatin 40 mg (Lipitor®) for 4 weeks
Ramipril 10 mg
A once daily oral dose of ramipril 10 mg (Altace®) for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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* Patients treated with BP lowering and / or lipid lowering medication can be included if the medication can be safely withdrawn as per physician's judgment.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.
Exclusion Criteria
* 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
* Medical history or evidence of drug or alcohol abuse.
* Medical history of gastrointestinal bleeding or gastroduodenal ulcer.
* Presence of secondary dyslipidemia.
* For patients on antihypertensive and/ or cholesterol lowering medication impossibility to withdraw it safely as per physician's judgment
* Previous coronary artery bypass graft (CABG).
* Previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.
* Presence of severe congestive heart failure (New York Heart Classification (NYHC) III IV).
* Prior history of stroke, Transient Ischemic Attack (TIA), Myocardial Infarction (MI), and cardiomyopathy with systolic dysfunction (prior documented Left Ventricular Ejection Fraction (LVEF) \< 40%)
* Aspirin induced asthma
* Previous intolerance and/or hypersensitivity to ACE inhibitors, statins and/or salicylates.
* Presence of unstable angina.
* Lab values other than specified out of the central laboratory normal range considered clinically significant.
* Patients and their partners not using effective contraception methods (i.e. intra uterine device (IUD) and condom or diaphragm with spermicide and condom) during the study and for at least one month thereafter, oral contraceptives are allowed.
* Pregnant, lactating, breastfeeding, or intends to become pregnant during the course of the study (females only). All women must have a negative urine pregnancy test at the Screening Visit, be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or have a postmenopausal status (no menses) for at least one year.
* Presence of mental illness limiting the capacity for self-care.
* Presence of major systemic illnesses: renal disease, liver disease, neurological or psychiatric disease.
* Participation, in the 30 days preceding enrolment into the study, in any other clinical study in which investigational or marketed drugs were employed.
* Any other medical condition that in the investigators opinion may interfere with the study procedures and/or evaluations.
18 Years
74 Years
ALL
No
Sponsors
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Ferrer Internacional S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Ronald Surowitz
Role: PRINCIPAL_INVESTIGATOR
Health Awareness, Inc
Locations
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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
Clinical Research Source
Perrysburg, Ohio, United States
Einstein Clinical Research
Lancaster, South Carolina, United States
Punzi Medical Center
Carrollton, Texas, United States
Cullen Research, LLC
Houston, Texas, United States
Research Trials Worldwide LLC
Humble, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Deleon Research, PLLC
Plano, Texas, United States
Physician PrimeCare Research Institute, PLLC dba H
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Sylvana Research
San Antonio, Texas, United States
Chysalis Clinical Research
St. George, Utah, United States
Countries
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Other Identifiers
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FCD-PP-1501
Identifier Type: -
Identifier Source: org_study_id
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