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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00816829
Other study ID # C LF178P 05 01
Secondary ID 2005-000548-98
Status Terminated
Phase Phase 2
First received January 2, 2009
Last updated July 17, 2009
Start date September 2005
Est. completion date January 2008

Study information

Verified date July 2009
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.


Recruitment information / eligibility

Status Terminated
Enrollment 34
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway Pressure (CPAP) or presenting clinical symptoms of sleep apnea

- Overweight or obese, with BMI >= 25 kg/m² and < 40 kg/m².

- Known moderate hypertriglyceridemia, with fasting Triglycerides level >= 2.0 and < 6.0 mmol/L within 3 months before the inclusion.

Exclusion Criteria:

- indication for immediate CPAP

- other known endocrine disease, except treated and adequately controlled hypothyroidism

- renal failure or plasma creatinine level >130 µmol/L

- current chronic liver disease or ALanine Amino Transferase (ALT)> 2 times the upper normal limit (UNL)

- symptomatic gallbladder disease

- known muscular disease or creatine phosphokinase (CK) > 3 times UNL.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Placebo
Fenofibrate-matching placebo tablet
Fenofibrate
145 mg NanoCrystal tablet

Locations

Country Name City State
France Site 1 Paris

Sponsors (1)

Lead Sponsor Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Obstructive Apneas at one month of treatment No
Primary Desaturations at one month of treatment No
Primary Sleep Time With Oxygen Saturation Below 90% at one month of treatment No
Primary Apneas at one month of treatment No
Primary Hypopneas at one month of treatment No
Primary Index Apnea/Hypopnea at one month of treatment No
Primary Mixed Apneas at one month of treatment No
Primary Central Apneas at one month of treatment No
Primary Index of Apneas at one month of treatment No
Primary Index of Hypopneas at one month of treatment No
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