Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

NCT ID: NCT01362218

Last Updated: 2013-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Elevated LDL Cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

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 8 weeks.

Simvastatin

Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid

Group Type ACTIVE_COMPARATOR

Simvastatin, ramipril, acetylsalicylic acid

Intervention Type DRUG

A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks

Interventions

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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.

Intervention Type DRUG

Simvastatin, ramipril, acetylsalicylic acid

A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferrer Internacional S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clinic

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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P-100820-01

Identifier Type: -

Identifier Source: org_study_id

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