EUCTR2005-000733-37-SE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, multicenter parallel-group dose ranging clinical trial to assess the efficacy and safety of Org 4419-2 in the treatment of obstructive sleep apnea/hypopnea syndrome
V Organon0 个研究点目标入组 100 人开始时间: 2005年6月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •subjects with unstable or insufficiently treated co-morbid disease (except obesity, mild hypertension (WHO 1999 criteria: systolic BP<160 mmHg and/or diastolic BP <100 mmHg) or impaired glucose tolerance);
- •subjects who are institutionalized;
- •subjects with a current episode or history of depression or bipolar disorder or a family history of suicide;
- •subjects who currently fulfill criteria for central sleep apnea-hypopnea syndrome or Cheyne-Stokes syndrome, periodic limb movement disorder or other dyssomnias or parasomnias (ICSD 1997);
- •subjects who had UPPP or other type of surgery for OSAHS;
- •subjects who are working on shift times;
- •subjects with a BMI > 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 <40 ml/min/1.73 m2) or hepatic impairment;
- •subjects with prior intolerance or hypersensitivity to mirtazapine;
- •subject who in the judgment of the investigator are unwilling or unable to adequately comply with trial procedures or adequately communicate with the investigator;
- •pregnancy, lactation or females of childbearing potential not practicing adequate contraceptive measures (using oral contraceptive, a barrier method in combination with a spermicidal agent or who are surgically sterilized);
- •subjects with documented alcohol- or drug abuse within one year of screening; a positive result for drugs of abuse and disallowed medications in their screening lab results; or subjects drinking more than 14 units of alcohol per week;
- •subjects who have any clinically significant abnormal laboratory data (e.g., aspartate amino transferase (ASAT) and/or alanine amino transferase (ALAT) values > 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 < 90% or >10% of sleeping time at a saturation <75% in the screening PSG);
- •subjects with asystoles >3 sec on the screening PSG.
研究者
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