Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

This study has been terminated.
(Per sponsor's decision)
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362218

Locations
Spain
Hospital Clinic
Barcelona, Spain
Sponsors and Collaborators
Ferrer Internacional S.A.
  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
Contraceptives, Oral
Ramipril
Simvastatin
Analgesics
Analgesics, Non-Narcotic
Angiotensin-Converting Enzyme Inhibitors
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Contraceptive Agents
Contraceptive Agents, Female
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014