A post marketing, multicentre, single-arm, prospective clinical trial to assess the safety and efficacy of FDC of Propranolol Hydrochloride IP Plus Clonazepam IP Tablets in patients with anxiety disorders.â€
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- The proportion of participants who experienced at least one adverse event (AE)
研究概览
简要总结
A post marketing, multicentre, single-arm, prospective clinical trial to assess the safety and efficacy of FDC of PROPRANOLOL HYDROCHLORIDE IP + CLONAZEPAM IP Tablets in patients with anxiety disorders.â€
Primary Objective
To assess the safety of FDC PROPRANOLOL HYDROCHLORIDE IP 10MG / 10MG / 20MG / 20MG + CLONAZEPAM IP 0.25MG / 0.5MG / 0.25MG / 0.5MG Tablets in patients with anxiety disorders
Secondary Objective
To assess the efficacy of FDC PROPRANOLOL HYDROCHLORIDE IP 10MG / 10MG / 20MG /20MG + CLONAZEPAM IP 0.25MG / 0.5MG / 0.25MG / 0.5MG Tablets in patients with anxiety disorders.
Investigational product
Fixed dose combination (FDC) of PROPRANOLOL HYDROCHLORIDE IP IP 10MG / 10MG / 20MG /20MG + CLONAZEPAM IP 0.25MG / 0.5MG / 0.25MG /0.5MG Tablets
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients age
- •65 years.
- •Primary diagnosis of generalized anxiety disorder (GAD) either moderate or severe as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as confirmed by the MINI at Screening, in addition to a psychiatric evaluation by a board- certified or Biohavenapproved board-eligible psychiatrist; The duration of illness must be ≥ 1 year
- •Hamilton Anxiety Scale (HAM-A) score at least
- •Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed.
- •Literate and can understand and sign informed consent.
- •Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline.
排除标准
- •Pregnant and lactating female patients.
- •Hypersensitivity and/or skin reactions to drug constituents
- •Patients with congestive heart failure
- •Patients with bronchospastic lung disease, or severe respiratory insufficiency
- •Patients planned to be undergoing any major surgery
- •Patients with diabetes and specifically prone to hypoglycaemia
- •Patients with a history of hypothyroidism
- •Wolf-Parkinson-White Syndrome and tachycardia
- •Patients with impaired hepatic or renal function
- •Patients with sleep apnoea, myasthenia gravis and narrow-angle glaucoma.
- •Patients using any of the prohibited medications: a) Opioids) Use of alcohol/CNS depressants c) Antiepileptic drugs phenytoin, phenobarbital, carbamazepine, lamotrigine and valproate d) drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways e) Cardiovascular drugs: antiarrhythmics, Digitalis Glycosides, Calcium Channel Blockers, ACE Inhibitors, Alpha Blockers, Reserpine, inotropic agents, Isoproterenol and Dobutamine, f) Nonsteroidal Anti-Inflammatory Drugs, Antidepressants, Anesthetic Agents, Warfarin, Neuroleptic Drugs, Thyroxine.
结局指标
主要结局
The proportion of participants who experienced at least one adverse event (AE)
时间窗: Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6
•Proportion of discontinuations due to AEs
时间窗: Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6
•Incidence of Serious AEs
时间窗: Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6
•Changes in the laboratory parameters from baseline to the end of treatment.
时间窗: Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6
次要结局
- Clinical Global Impression-Severity Scale (CGI-S)(Clinical Global Impression-Anxiety Scale (CGI-anxiety))