A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT01004705
First received: October 23, 2009
Last updated: July 31, 2012
Last verified: July 2012
  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 simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.


Condition Intervention Phase
Elevated LDL Cholesterol
Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),
Drug: Simvastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Study of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril in Subjects With Elevated LDL Cholesterol

Resource links provided by NLM:


Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:
  • The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period. [ Time Frame: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2 ] [ Designated as safety issue: No ]
    Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.


Secondary Outcome Measures:
  • The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period. [ Time Frame: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2 ] [ Designated as safety issue: No ]
    Change from baseline in mean total cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.


Enrollment: 36
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fixed Dose Combination Pill
Once daily oral dose of combination of acetylsalicylic acid, simvastatin, and ramipril (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 or 10 mg 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 12 weeks.
Active Comparator: Simvastatin
Once daily oral dose of Simvastatin 40 mg
Drug: Simvastatin
A once daily oral dose of simvastatin for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects ≥18 years of age
  • Previously untreated LDL cholesterol ≥100 mg/dL and ≤180 mg/dL.
  • Provide written informed consent.

Exclusion Criteria:

  • Subjects with a medical condition requiring chronic pharmacological treatment
  • On direct questioning and physical examination have evidence of any clinically significant chronic disease, including known or suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
  • On direct questioning and physical examination have a medical history or evidence of abuse of drugs.
  • Medical history of gastrointestinal bleeding or gastric or duodenal ulcer.
  • Systolic pressure ≥140 mmHg or diastolic pressure >89 mmHg requiring hypotensive medication.
  • Presence of secondary dyslipidemia.
  • Previous use of cholesterol lowering medication.
  • 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).
  • Presence of untreated or uncontrolled thyroid disease.
  • Past or current medical history of asthma or aspirin induced asthma
  • Previous hypersensitivity to ACE inhibitors (eg angioedema or cough).
  • Previous hypersensitivity to ARBs.
  • History of unstable angina.
  • Serum creatinine >2 mg/dL.
  • Creatine phosphokinase (CPK) ≥5 x the upper limit of normal (ULN).
  • Hemoglobin ≤12 g/dL (120 g/L) for male subjects or ≤10 g/dL (100 g/L) for female subjects.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN.
  • Total bilirubin ≥1.5 x ULN.
  • Serum triglyceride concentration ≥400 mg/dL.
  • Subjects not using effective contraception methods (intra uterine device [IUD] and condom or diaphragm with spermicide and condom) during the study and for at least one month thereafter.
  • 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.
  • Contraindications to or known or suspected hypersensitivity to aspirin, simvastatin or ramipril or their excipients.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004705

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.
  More Information

No publications provided

Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT01004705     History of Changes
Other Study ID Numbers: P-080647-01
Study First Received: October 23, 2009
Results First Received: June 1, 2012
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferrer Internacional S.A.:
cardiovascular
fixed
dose
combination
pill
LDL
cholesterol

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 April 14, 2014