/A

Active, not recruiting

• Conditions: The objective is to explore the efficacy of pharmacological weight reduction compared with CPAP treatment in patients with moderate to severe obstructive sleep apnea (OSA).; MedDRA version: 12.0Level: LLTClassification code 10055577Term: Obstructive sleep apnea syndrome

• Registration Number: EUCTR2009-015859-24-SE
• Lead Sponsor: The Sahlgrenska Academy, University of Gothenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-22
• Last Update Posted: 25 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Provision of informed consent prior to any study specific procedures
2.Males/females 18 to 75 years
3.An Apnea-Hypopnea Index (AHI)>15 and an Epworth Sleepiness Scale score (ESS)>6
4.Body mass index (BMI) between >27 and <35 kg/m2 (mild to moderate)
5.Clinically normal physical findings and laboratory values, as judged by the investigator

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Hypersensitivity to sulfonamides or zonisamide.
2.History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
3.Subjects with a seizure disorder
4.Clinically significant renal (serum creatinine >2.0 mg/dL or >130 ?mol/L), neurological, metabolic (e.g. Type 1 or 2 diabetes), haematological or hepatic disease (ASAT or ALAT >2 times the upper limit of normal).
5.Subjects who have taken any weight loss medications (prescription or over-the-counter) within one month prior to Enrollment
6.Subjects with occupations designated as high risk or safety sensitive including patients who have to handle complex machinery or are professional drivers where there may be an increased risk for work or traffic accidents.
7.Unstable angina pectoris, unstable hypertension (diastolic blood pressure above 100 on treatment for more than 3 months), diabetes (fasting plasma glucose above 7 mmoles/l)
8.Uncontrolled congestive heart failure
9.Myocardial infarction or coronary vessel intervention within the previous 6 months period
10.Subjects with uncontrolled hypertension (defined as a diastolic blood pressure ?100 mmHg and/or a systolic blood pressure =180 mmHg with or without medication). Hypertensive subjects on medications must have been on the same dose of the same antihypertensive medication for at least two months prior to Enrollment.
11.Previously diagnosed or treated clinically significant cardiac arrhythmia
12.Clinically significant chronic pulmonary or gastrointestinal disease
13.Clinical history of depression as judged by the investigator or other previous or present clinically significant psychiatric disease
14.Pregnancy or lactation. Women of childbearing potential should use effective birth control prior to and during the study
15.Suspected or confirmed poor compliance
16.Alcohol or drug abuse during the last year
17.Subjects with any other significant condition that, in the opinion of the investigator, could interfere with participation in the study.
18.Severe nocturnal hypoxia defined as more than 10 episodes with an oxygen desaturation exceeding 50% or signs of lacking resaturation between desaturations on previous recordings according to investigators judgement.
19.Participation in another clinical study during the last 6 months
20.Inability to understand and complete the questionnaires

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified