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A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.

NCT ID: NCT00349635

Last Updated: 2007-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Metformin and Metformin + Fenofibrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Both genders, BMI ≥ 30 kg/m² and \<40 kg/m².

Exclusion Criteria

* Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 1

Helsinki, , Finland

Site Status

Site 3

Kuopio, , Finland

Site Status

Site 2

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2004-001731-28

Identifier Type: -

Identifier Source: secondary_id

C LF23-0121 04 01

Identifier Type: -

Identifier Source: org_study_id