- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02791958
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
Pharmacodynamic Equivalence Study of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular Fixed Dose Combination Pill AAR as Compared to Monotherapy With the Reference Products Altace® 10 mg and Lipitor® 40 mg
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35209
- Central Alabama Research
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California
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Los Angeles, California, United States, 90057
- National Research Institute
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Sacramento, California, United States, 95821
- Clinical Trials Research
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Tustin, California, United States, 92780
- Clinical Trials Investigators, Inc
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West Hills, California, United States, 91307
- Infoshpere Clinical Research, Inc
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Florida
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Bradenton, Florida, United States, 34208
- Meridien Research
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Brandon, Florida, United States, 33511
- PAB Clinical Research
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Coral Gables, Florida, United States, 33134
- Clinical Research of South Florida
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Coral Gables, Florida, United States, 33134
- Clinical Therapeutics Corporation
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Doral, Florida, United States, 33166
- Moonshine Research Center, Inc
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Edgewater, Florida, United States, 32132
- Riverside Clinical Research
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Hialeah, Florida, United States, 33013
- Nova Clinical Research Center Inc
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Homestead, Florida, United States, 33030
- Dr. John C. Gutleber Weight Loss, Beauty, and Family Practice
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Jacksonville, Florida, United States, 32205
- Westside Center for Clinical Research
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Jacksonville, Florida, United States, 32216
- Jacksonville Center for Clinical Research
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Jupitor, Florida, United States, 33458
- Health Awareness, Inc.
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Kissimmee, Florida, United States, 34744
- The Chappel Group Research
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Lauderdale Lakes, Florida, United States, 33319
- Sunrise Medical Center
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Port Orange, Florida, United States, 32127
- Progressive Medical Research
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St. Petersburg, Florida, United States, 33709
- Meridien Research
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Illinois
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Chicago, Illinois, United States, 60607
- Cedar Crosse Research Center
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Kentucky
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Louisville, Kentucky, United States, 40213
- Louisville Metabolic and Atherosclerosis Research
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Louisiana
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Monroe, Louisiana, United States, 71201
- Clinical Trials of America LA, LLC
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New Orleans, Louisiana, United States, 70124
- DelRicht Research
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Massachusetts
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Watertown, Massachusetts, United States, 02472
- Bay State Clinical Trials, Inc
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Ohio
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Perrysburg, Ohio, United States, 43551
- Clinical Research Source
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South Carolina
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Lancaster, South Carolina, United States, 29720
- Einstein Clinical Research
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Texas
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Carrollton, Texas, United States, 75006
- Punzi Medical Center
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Houston, Texas, United States, 77051
- Cullen Research, LLC
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Humble, Texas, United States, 77338
- Research Trials Worldwide LLC
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New Braunfels, Texas, United States, 78130
- Central Texas Health Research
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Plano, Texas, United States, 75093
- Deleon Research, PLLC
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San Antonio, Texas, United States, 78229
- Diagnostics Research Group
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San Antonio, Texas, United States, 78229
- Sylvana Research
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San Antonio, Texas, United States, 78228
- Physician PrimeCare Research Institute, PLLC dba H
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Utah
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St. George, Utah, United States, 84790
- Chysalis Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CV Fixed Dose Combination Pill AAR
Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg).
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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.
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ACTIVE_COMPARATOR: Atorvastatin
Atorvastatin 40 mg (Lipitor®).
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A once daily oral dose of atorvastatin 40 mg (Lipitor®) for 4 weeks
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ACTIVE_COMPARATOR: Ramipril
Ramipril 10 mg (Altace®).
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A once daily oral dose of ramipril 10 mg (Altace®) for 4 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Difference in the adjusted mean 24-h systolic blood pressure results using ABPM between the baseline (week 0) and the final visit (week 8).
Time Frame: Measures at baseline visit (week 0) and final visit (week 8).
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Measures at baseline visit (week 0) and final visit (week 8).
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Difference in LDL cholesterol levels between the baseline (week 4) and the final visit (week 8).
Time Frame: Measures at baseline visit (week 4) and final visit (week 8).
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Measures at baseline visit (week 4) and final visit (week 8).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the adjusted mean 24-h diastolic blood pressure results (using ABPM) between the basal and the final visits.
Time Frame: Measures at baseline visit (week 0) and final visit (week 8).
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Measures at baseline visit (week 0) and final visit (week 8).
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Difference in the adjusted mean 24-h mean arterial pressure results (using ABPM) between the basal and the final visits.
Time Frame: Measures at baseline visit (week 0) and final visit (week 8).
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Measures at baseline visit (week 0) and final visit (week 8).
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Difference in the adjusted mean 24-h heart rate results (using ABPM) between the basal and the final visits.
Time Frame: Measures at baseline visit (week 0) and final visit (week 8).
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Measures at baseline visit (week 0) and final visit (week 8).
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Difference in Very Low-Density Lipoprotein (VLDL) cholesterol levels between the basal and the final visits.
Time Frame: Measures at baseline visit (week 0) and final visit (week 8).
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Measures at baseline visit (week 0) and final visit (week 8).
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Difference in HDL cholesterol levels between the basal and the final visits.
Time Frame: Measures at baseline visit (week 0) and final visit (week 8).
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Measures at baseline visit (week 0) and final visit (week 8).
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Difference in total cholesterol levels between the basal and the final visits.
Time Frame: Measures at baseline visit (week 0) and final visit (week 8).
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Measures at baseline visit (week 0) and final visit (week 8).
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Difference in triglyceride levels between the basal and the final visits.
Time Frame: Measures at baseline visit (week 0) and final visit (week 8).
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Measures at baseline visit (week 0) and final visit (week 8).
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Through study completion, an average of 3 months.
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AEs, clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), vital signs, electrocardiogram (ECG), and physical examination. The total number of patients with at least one AE and the number of AEs will be included in listings and tabulations. AEs will be coded using MedDRA, classified by system organ class (SOC) and preferred term and tabulated by intensity and causal relationship for each treatment. |
Through study completion, an average of 3 months.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Antimetabolites
- Protease Inhibitors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Angiotensin-Converting Enzyme Inhibitors
- Atorvastatin
- Ramipril
Other Study ID Numbers
- FCD-PP-1501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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