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
1 other identifier
interventional
528
1 country
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hypertension
Started Mar 2016
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedApril 10, 2017
April 1, 2017
1.6 years
February 15, 2016
April 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Difference in the adjusted mean 24-h systolic blood pressure results using ABPM between the baseline (week 0) and the final visit (week 8).
Measures at baseline visit (week 0) and final visit (week 8).
Difference in LDL cholesterol levels between the baseline (week 4) and the final visit (week 8).
Measures at baseline visit (week 4) and final visit (week 8).
Secondary Outcomes (8)
Difference in the adjusted mean 24-h diastolic blood pressure results (using ABPM) between the basal and the final visits.
Measures at baseline visit (week 0) and final visit (week 8).
Difference in the adjusted mean 24-h mean arterial pressure results (using ABPM) between the basal and the final visits.
Measures at baseline visit (week 0) and final visit (week 8).
Difference in the adjusted mean 24-h heart rate results (using ABPM) between the basal and the final visits.
Measures at baseline visit (week 0) and final visit (week 8).
Difference in Very Low-Density Lipoprotein (VLDL) cholesterol levels between the basal and the final visits.
Measures at baseline visit (week 0) and final visit (week 8).
Difference in HDL cholesterol levels between the basal and the final visits.
Measures at baseline visit (week 0) and final visit (week 8).
- +3 more secondary outcomes
Study Arms (3)
CV Fixed Dose Combination Pill AAR
EXPERIMENTALCardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg).
Atorvastatin
ACTIVE COMPARATORAtorvastatin 40 mg (Lipitor®).
Ramipril
ACTIVE COMPARATORRamipril 10 mg (Altace®).
Interventions
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.
A once daily oral dose of atorvastatin 40 mg (Lipitor®) for 4 weeks
Eligibility Criteria
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.
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Central Alabama Research
Birmingham, Alabama, 35209, United States
National Research Institute
Los Angeles, California, 90057, United States
Clinical Trials Research
Sacramento, California, 95821, United States
Clinical Trials Investigators, Inc
Tustin, California, 92780, United States
Infoshpere Clinical Research, Inc
West Hills, California, 91307, United States
Meridien Research
Bradenton, Florida, 34208, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, 33134, United States
Moonshine Research Center, Inc
Doral, Florida, 33166, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
Nova Clinical Research Center inc
Hialeah, Florida, 33013, United States
Dr. John C. Gutleber Weight Loss, Beauty, and Family Practice
Homestead, Florida, 33030, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Health Awareness, Inc.
Jupitor, Florida, 33458, United States
The Chappel Group Research
Kissimmee, Florida, 34744, United States
Sunrise Medical Center
Lauderdale Lakes, Florida, 33319, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Louisville Metabolic and Atherosclerosis Research
Louisville, Kentucky, 40213, United States
Clinical Trials of America LA, LLC
Monroe, Louisiana, 71201, United States
DelRicht Research
New Orleans, Louisiana, 70124, United States
Bay State Clinical Trials, Inc
Watertown, Massachusetts, 02472, United States
Clinical Research Source
Perrysburg, Ohio, 43551, United States
Einstein Clinical Research
Lancaster, South Carolina, 29720, United States
Punzi Medical Center
Carrollton, Texas, 75006, United States
Cullen Research, LLC
Houston, Texas, 77051, United States
Research Trials Worldwide LLC
Humble, Texas, 77338, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Deleon Research, PLLC
Plano, Texas, 75093, United States
Physician PrimeCare Research Institute, PLLC dba H
San Antonio, Texas, 78228, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Sylvana Research
San Antonio, Texas, 78229, United States
Chysalis Clinical Research
St. George, Utah, 84790, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Surowitz
Health Awareness, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2016
First Posted
June 7, 2016
Study Start
March 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
April 10, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share