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

August 12, 2024 updated by: Organon and Co

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of treatment is 12 weeks.

Study Type

Interventional

Enrollment (Actual)

571

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elevated cholesterol level

Exclusion Criteria:

  • Liver disease
  • Known allergies to study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fasting triglyceride levels at 12 weeks.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2002

Primary Completion (Actual)

March 3, 2003

Study Completion (Actual)

March 4, 2003

Study Registration Dates

First Submitted

September 21, 2004

First Submitted That Met QC Criteria

September 23, 2004

First Posted (Estimated)

September 24, 2004

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0733-224
  • 2004_060

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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