A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure
This study has been terminated.
Sponsor:
Ferrer Internacional S.A.
Information provided by (Responsible Party):
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT01005290
First received: October 22, 2009
Last updated: June 20, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Combination pill Drug: Ramipril |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Interaction Study to Evaluate the Effect of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin and Ramipril (Cardiovascular Fixed Dose Combination Pill) on Blood Pressure |
Resource links provided by NLM:
Further study details as provided by Ferrer Internacional S.A.:
Primary Outcome Measures:
- Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period. [ Time Frame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 ] [ Designated as safety issue: No ]Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.
Secondary Outcome Measures:
- Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period [ Time Frame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 ] [ Designated as safety issue: No ]Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period
| Enrollment: | 38 |
| Study Start Date: | October 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combination pill
A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
|
Drug: Combination pill
A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
|
|
Active Comparator: Ramipril
A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.
|
Drug: Ramipril
A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects will be ≥18 years old
- Previously untreated systolic pressure result of ≥120<160 mmHg and diastolic pressure result of ≥80<100 mmHg
Exclusion Criteria:
- Subjects must not have previously received any anti-hypertensive medication
- must not have a systolic pressure <120 mmHg or ≥160 mmHg and diastolic pressure result of <80 mmHg or ≥100 mmHg
- must not have had a previous coronary artery bypass graft (CABG)
- must not have had a previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent
- must not have severe congestive heart failure (New York Heart Classification [NYHC] III-IV).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005290
Locations
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, NY 10029-6574 | |
Sponsors and Collaborators
Ferrer Internacional S.A.
Investigators
| Principal Investigator: | Valentin Fuster, MD, PhD | Mount Sinai School of Medicine |
More Information
No publications provided
| Responsible Party: | Ferrer Internacional S.A. |
| ClinicalTrials.gov Identifier: | NCT01005290 History of Changes |
| Other Study ID Numbers: | P-080646-01 |
| Study First Received: | October 22, 2009 |
| Results First Received: | March 30, 2012 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ferrer Internacional S.A.:
|
cardiovascular fixed dose |
combination pill hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Aspirin Ramipril Simvastatin Contraceptives, Oral Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents |
Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 23, 2013