Obstructive sleep apnea/hypopnea syndrome MedDRA version: 8.0 Level: LLT Classification code 10055577
Conditions
Interventions
Product Name: Org 4419-2
Product Code: Org 4419-2
Pharmaceutical Form: Tablet
CAS Number: 680993-88-8
Current Sponsor code: Org 4419-2
Other descriptive name: Maleic acid salt of R-enantiomer of the r
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • must provide written informed consent after the scope and nature of the investigation have been explained to them, before screening evaluations; • must be able to speak, read and understand the local language and possess the ability to respond to questions, follow instructions and complete questionnaires; • fulfill AASM (1999) criteria for OSAHS; • have an AHI =10 (events/h) at the screening PSG; • screening PSG is based on = 6 h time in bed and = 4 h total sleep time; • males and females aged 18-65 years; • no current treatment with CPAP or oral appliances (if treated with prior CPAP or oral appliances, this must have been discontinued =3 weeks prior to trial baseline); • no current treatment with modafinil, methylphenidate or other psychostimulant drugs (such prior psychostimulant treatment must have been discontinued =3 weeks prior to trial baseline). 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • subjects with unstable or insufficiently treated co-morbid disease (except obesity, mild hypertension (WHO 1999 criteria: systolic BP 45 kg/m2; • subjects who are currently treated, or had prior treatment within 3 weeks of baseline, with any antidepressant, 5HT3 antagonists (ondansetron, granisetron, tropisetron etc), 5HT1 agonists (triptans, buspirone), 5HT4 agonists (IBS treatments), antipsychotics, benzodiazepines and nonbenzodiazepine hypnotics and sedatives (including the use of sedative antihistaminergic drugs), opiates, acetazolamide and theophylline; • subjects who are treated with progestagens, of which the dose regimen of the progestagen was changed from 28 days before baseline until baseline; • subjects who have enrolled in experimental trials for the treatment of OSAHS within 3 months of screening or have ever participated in a Org 3770 or Org 50081 clinical trial; • laboratory evidence of hypothyroidism; • subjects with Marfan’s syndrome, acromegaly, congestive heart failure, congenital or hereditary disorders with cranial or maxillary abnormalities or hereditary metabolic disorders; • subjects with moderate and severe renal impairment (GFR 2x normal range upper limit) or ECG results, or a clinically significant abnormal outcome at the physical examination at the screening visit; • subjects who had a car accident in the 12 months before the screening period or for whom prolonged daytime sleepiness would be an unacceptable risk (e.g. professional drivers); • subjects with COPD or respiratory insufficiency from any cause (e.g. waking oxygen saturation 10% of sleeping time at a saturation 3 sec on the screening PSG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Org 4419-2 in decreasing the Apnea Hypopnea Index (AHI) as compared to placebo.;Secondary Objective: • to explore the efficacy of Org 4419-2 in improving secondary PSG parameters, clinical global impression, MSLT, snoring frequency, daytime sleepiness, functional status and quality of life in OSAHS as compared to placebo; • to explore a dose-response and/or plasma concentration-response relationship in the efficacy of Org 4419-2; • to assess the plasma concentration of Org 4419-2, Org 4420, Org 31602 and Org 31603 in OSAHS subjects; • to assess the safety and tolerability of Org 4419-2, including the key safety aspects of weight gain and sedation; • to assess whether in-vivo conversion of Org 4419 into Org 4420 and/or invivo conversion of Org 31602 into Org 31603 occurs.;Primary end point(s): The change from baseline in overall Apnea Hypopnea Index (AHI) at Day 28. | — |
Countries
Spain, Sweden
Outcome results
None listed