Completed PHASE3 INTERVENTIONAL 3-arm NCT00459745

A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia

A Multi-Center, Prospective, Longitudinal, Randomized, Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of Daily Administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the Combination of Pravastatin and Fenofibrate 40/160 mg) for 12 Weeks Followed by a 52-Week Open-Label Safety Phase of the Pravafen Alone in the Treatment of Combined Hyperlipidemia.

Sponsor: Integrium

Conditions Combined Hyperlipidemia

Interventions Fenofibrate Pravafen Pravastatin

Updated 8 times since 2017 Last updated: Apr 20, 2018 Started: Apr 30, 2007 Primary completion: Apr 30, 2008 Completion: Jul 31, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Combined Hyperlipidemia, this trial is completed. The trial is conducted by Integrium and has accumulated 8 data snapshots since 2007. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Apr 2022 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Apr 2022 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
May 2018 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — May 2018 [monthly]

Completed PHASE3

First recorded

Apr 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Integrium
Shionogi

Data source: Shionogi Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Auburn, United States , Austin, United States , Baltimore, United States , Bartlesville, United States , Berlin, United States , Bristol, United States , Charlotte, United States , Cincinnati, United States , Eugene, United States and 39 more locations