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

NCT ID: NCT01004705

Last Updated: 2012-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-03-31

Brief Summary

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.

Conditions

Elevated LDL Cholesterol

Keywords

cardiovascular; fixed; dose; combination; pill; LDL; cholesterol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),

Intervention Type: DRUG

A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks.

Simvastatin

Once daily oral dose of Simvastatin 40 mg

Group Type: ACTIVE_COMPARATOR

Simvastatin

Intervention Type: DRUG

A once daily oral dose of simvastatin for 12 weeks.

Interventions

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.

Intervention Type: DRUG

Simvastatin

A once daily oral dose of simvastatin for 12 weeks.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferrer Internacional S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mount Sinai Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

P-080647-01

Identifier Type: -

Identifier Source: org_study_id