Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)

A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Tolerability and Efficacy of the Co-Administration of Simvastatin 20 mg/Day and Fenofibrate 160 mg/Day Compared to Simvastatin 20 mg/Day Alone for 12 Weeks of Treatment in Patients With Combined Hyperlipidemia-Simvastatin and Fenofibrate Efficacy Trial (SAFARI)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092157

Enrollment

571

Registered

2004-09-24

Start date

2002-05-01

Completion date

2003-03-04

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

High cholesterol

Brief summary

The purpose of this study is to evaluate the safety and effectiveness of two approved drugs in lowering high cholesterol when taken together, compared to taking only one of the drugs.

Detailed description

The duration of treatment is 12 weeks.

Interventions

DRUGMK0733, simvastatin

DRUGComparator: simvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Elevated cholesterol level

Exclusion criteria

* Liver disease * Known allergies to study drugs

Design outcomes

Primary

Measure	Time frame
Fasting triglyceride levels at 12 weeks.	—

Secondary

Measure	Time frame
Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026