NCT00349375 is a Phase 3 clinical trial of Fenofibrate/Simvastatin in Hyperlipidemia, sponsored by Solvay Pharmaceuticals.

Who is sponsoring NCT00349375?

NCT00349375 is sponsored by Solvay Pharmaceuticals.

What drugs are being tested in NCT00349375?

Interventions in NCT00349375: Fenofibrate/Simvastatin, Fenofibrate/Simvastatin, Simvastatin.

What condition does NCT00349375 study?

NCT00349375 studies Hyperlipidemia.

Is NCT00349375 still recruiting?

NCT00349375 is currently completed. Last updated 7 July 2009.

Last reviewed 2009-07-07 · How we verify

NCT00349375

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Double-Blind, Randomized, Active Comparator, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone

Completed Phase 3 Last updated 7 July 2009

What this trial tests

Phase 3 trial testing Fenofibrate/Simvastatin in Hyperlipidemia in 1,040 participants. Completed in 1 September 2008.

Timeline

1 November 2005

Primary endpoint
1 September 2008

1 September 2008

Quick facts

Lead sponsor	Solvay Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,040
Start date	1 November 2005
Primary completion	1 September 2008
Estimated completion	1 September 2008
Sites	110 locations across Czechia, Denmark, France, Germany, Hungary, Netherlands, Poland, Ukraine

Drugs / interventions tested

Fenofibrate/Simvastatin — full drug profile →
Fenofibrate/Simvastatin — full drug profile →
Simvastatin (simvastatin) — full drug profile →

Conditions studied

Hyperlipidemia — all drugs for Hyperlipidemia →

Sponsor

Solvay Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Hyperlipidemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percent change from baseline to 24 weeks of treatment in Triglycerides
Time frame: 12 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
Time frame: 12 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
Time frame: 12 weeks

Sponsor's own description

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hyperlipidemia

Currently open trials in the same condition.

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NCT07216482 — A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037) · Phase 3 · recruiting
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NCT07400549 — Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support T · NA · recruiting
NCT06603363 — Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00349375 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Solvay Pharmaceuticals
Last refreshed: 7 July 2009

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00349375.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing