Effect of Fenofibrate on Sleep Apnea Syndrome

NCT00816829 | Terminated Phase 2 Results

• 2 other identifiers: C LF178P 05 012005-000548-98
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyslipidemia; Sleep Apnea Syndrome; Overweight; Obesity

Keywords

Dyslipidemia; Sleep Apnea Syndromes; Fenofibrate; Obese; Overweight or obese patients

Outcome Measures

Primary Outcomes (10)

• Obstructive Apneas

  Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).

  at one month of treatment

• Desaturations

  Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.

  at one month of treatment

• Sleep Time With Oxygen Saturation Below 90%

  Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.

  at one month of treatment

• Apneas

  Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment

  at one month of treatment

• Hypopneas

  Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.

  at one month of treatment

• Index Apnea/Hypopnea

  Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.

  at one month of treatment

• Mixed Apneas

  Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.

  at one month of treatment

• Central Apneas

  Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.

  at one month of treatment

• Index of Apneas

  Average number of apneas per hour of sleep during one night after one month of treatment.

  at one month of treatment

• Index of Hypopneas

  Average number of hypopneas per hour of sleep during one night after one month of treatment.

  at one month of treatment

Study Arms (2)

1

PLACEBO COMPARATOR

Fenofibrate-matching placebo tablet

Drug: Placebo

2

EXPERIMENTAL

145 mg NanoCrystal fenofibrate tablet

Drug: Fenofibrate

Interventions

Placebo DRUG

Fenofibrate-matching placebo tablet

1

Fenofibrate DRUG

145 mg NanoCrystal tablet

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Solvay Pharmaceuticals: lead

Study Sites (1)

Site 1

Paris, France

Location

Related Publications (1)

• Bruckert E, Duchene E, Bonnefont-Rousselot D, Hansel B, Ansquer JC, Dubois A, Gaymard B. Proof of concept study: does fenofibrate have a role in sleep apnoea syndrome? Curr Med Res Opin. 2010 May;26(5):1185-92. doi: 10.1185/03007991003693581.

  PMID: 20297950 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Sleep Apnea Syndromes; Overweight; Obesity

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Limitations and Caveats

Only treatment emergent events have been presented. They are defined as events started at or after the 1st administration of study medication and includes events started prior to the 1st administration but which worsened after the 1st intake.

Results Point of Contact

• Title: Sven Voet, Global Communication
• Organization: Solvay Pharmaceuticals

sven.voet@solvay.com

+32 (0) 2 509 69 77

Study Officials

• Global Clinical Director Solvay

  Solvay Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 2, 2009
• First Posted: January 5, 2009
• Study Start: September 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 22, 2009
• Results First Posted: July 7, 2009

Record last verified: 2009-07

Locations

FR (1)