Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

Ferrer

Status and phase: Terminated; Phase 2

Conditions: Elevated LDL Cholesterol

Treatments: Drug: Simvastatin, ramipril, acetylsalicylic acid; Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01362218

P-100820-01

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Fixed Dose Combination Pill

Experimental group

Description:

A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)

Treatment:

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

Simvastatin

Active Comparator group

Description:

Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid

Treatment:

Drug: Simvastatin, ramipril, acetylsalicylic acid