---
title: Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome
nct_id: NCT00385658
overall_status: COMPLETED
phase: PHASE4
sponsor: Novartis
study_type: INTERVENTIONAL
primary_condition: Dyslipidemia
countries: Germany, Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00385658.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00385658"
ct_last_update_post_date: 2017-02-24
last_seen_at: "2026-05-12T07:32:03.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome

**Official Title:** A 16-week Multicenter, 2-period Study to Investigate the Effect of the Combination of Fluvastatin ER 80mg and Fenofibrate 200mg on HDL-C in Comparison to the Combination of Simvastatin 20mg and Ezetimibe 10mg in Patients With Metabolic Syndrome

**NCT ID:** [NCT00385658](https://clinicaltrials.gov/study/NCT00385658)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 75
- **Lead Sponsor:** Novartis
- **Conditions:** Dyslipidemia
- **Start Date:** 2006-08
- **Completion Date:** 2007-03
- **CT.gov Last Update:** 2017-02-24

## Brief Summary

This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

```
Inclusion Criteria:

* Written informed consent to participate in the study prior to any study procedures.
* Male or female subjects, age between 18-75 years inclusive.
* All women of child bearing potential must have a negative pregnancy test
* Metabolic Syndrome according to the International Diabetes Federation definition:

  * Low plasma HDL-C (Men \< 40 mg/dl ; Women \< 50 mg/dl ).
  * Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
  * And one or more of the following criteria:

    * Triglycerides ≥ 150 mg/d.l
    * Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.
    * Fasting plasma glucose≥ 100mg/dl.
    * Previously diagnosed type 2 diabetes.

Exclusion Criteria:

* Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
* Type 1 diabetes.
* HbA1c \> 9.5%.
* Unexplained serum creatine phosphokinase \> 2 x Upper limit of normal.
* History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
* Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.

Other protocol-defined inclusion/exclusion criteria may apply.
```

## Interventions

- **Fluvastatin extended release, fenofibrate** (DRUG)
- **Fixed combination simvastatin/ezetimibe** (DRUG)

## Primary Outcomes

- **High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.**

## Secondary Outcomes

- **Compared at the end of each treatment period:**
- **patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl**
- **patients reaching target levels of non-HDL-C <130mg/**
- **LDL-C/HDL-C**
- **Triglycerides**
- **LDL subfractions in a subgroup of patients**

## Locations (2)

- Investigative Centers, Germany
- Novartis Pharma AG, Basel, Switzerland

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.|investigative centers||germany` — added _(2026-05-12)_
- `locations.novartis pharma ag|basel||switzerland` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00385658*  
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