Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol
This study has been terminated.
(Per sponsor's decision)
Sponsor:
Ferrer Internacional S.A.
Information provided by (Responsible Party):
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT01362218
First received: May 26, 2011
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Elevated LDL Cholesterol |
Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril) Drug: Simvastatin, ramipril, acetylsalicylic acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Cardiovascular Fixed Combination Pill ASR: Pharmacodynamic Clinical Trial of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril (Cardiovascular Polypill); LDL Cholesterol |
Resource links provided by NLM:
Further study details as provided by Ferrer Internacional S.A.:
Primary Outcome Measures:
- Difference in LDL-cholesterol levels between the basal and the final visit of treatment period. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- • Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
- • Difference in HDL-cholesterol levels between the basal and the final visit of treatment period. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
- • Difference in total cholesterol levels between the basal and the final visit of treatment period. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
- • Difference in triglyceride levels between the basal and the final visit of treatment period [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
| Enrollment: | 107 |
| Study Start Date: | October 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fixed Dose Combination Pill
A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
|
Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks.
|
|
Active Comparator: Simvastatin
Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid
|
Drug: Simvastatin, ramipril, acetylsalicylic acid
A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects aged ≥18 and <75 years.
- Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid lowering drug for the last 4 weeks.
- LDL-cholesterol ≥130 and ≤220 mg/dL.
- Systolic blood pressure ≥120 and <160 mmHg and diastolic blood pressure ≥70 and <100 mmHg.
- Provide written informed consent.
Exclusion Criteria:
Contacts and Locations More Information
No publications provided
| Responsible Party: | Ferrer Internacional S.A. |
| ClinicalTrials.gov Identifier: | NCT01362218 History of Changes |
| Other Study ID Numbers: | P-100820-01 |
| Study First Received: | May 26, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Additional relevant MeSH terms:
|
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 Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 23, 2013