A Randomized, Double-Blind, Multicentric, Active Controlled, Phase IV Clinical Study to Evaluate the Safety, Efficacy and Tolerability of Fixed Dose Combination of Clonazepam 0.25 mg and Propranolol 10/20 mg In Patients With Anxiety Disorders
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Change in the score on the Hamilton Rating Scale for Anxiety (HAM-A) at the end of treatment(8th week) as compared to baseline
研究概览
简要总结
This is A randomized, double-blind, multicentric, active controlled Phase IV clinical study to evaluate the Safety, Efficacy and Tolerability of fixed dose combination of Clonazepam 0.25 mg and Propranolol 10/20 mg in patients with anxiety disorders.
The total sample size of trial is 150. The total duration of study is 8 week.
The clinical efficacy will be tested by the following parameter (Primary Outcome)
ï‚· Change in the score on the Hamilton Rating Scale for Anxiety (HAM-A) at the end of treatment(8th week) as compared to baseline
The clinical safety and efficacy will be tested by the following parameter
ï‚· Percentage of patients having a 50% reduction in the HAM-A total score at the end of the study (8th week) as compared to baseline
ï‚· Degree of improvement in the mean CGI-S (global severity of the CGI scale) score at the end of study (8th week) as compared to baseline.
ï‚· Safety and tolerability of the study drug will be assessed by monitoring vital signs, physical examination, ECG, clinically significant changes in laboratory parameters and adverse events
The safety of the drug(s) during the study will be monitored by adverse effect monitoring during patient visits or through telephonic information in between visits, & laboratory investigations.
The compliance will also be monitored by pill-counting the left over medication during patient visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 18- 65 years of age
- •Patients with established diagnosis of Anxiety (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM V)
- •Total Hamilton Rating Scale for Anxiety (HAM-A) score ≥17
- •CGI-S score greater than 4 in the week prior to inclusion of the study.
- •Willingness and able to give informed consent and comply with requirements for participation in the study.
排除标准
- •Pregnancy and/or lactation
- •Patients with a history of mania, schizophrenia, seizures, narrow angle glaucoma, pre-existing CNS depression or coma, respiratory depression, acute pulmonary insufficiency, hyper thyroidism, myasthenia gravis, diabetes mellitus, sleep apnoea, chronic pulmonary insufficiency and/or muscle weakness
- •Patients with suicidal tendencies
- •Patients operating hazardous machinery, including automobiles
- •Patients with renal and/or hepatic insufficiency
- •Patients who have a history of hypersensitivity to clonazepam and/or Propranolol and/or any components of the formulations
- •Patients with any other serious concurrent illness or malignancy
- •Participation in another clinical trial in the past 3 months.
结局指标
主要结局
Change in the score on the Hamilton Rating Scale for Anxiety (HAM-A) at the end of treatment(8th week) as compared to baseline
时间窗: Baseline to week 8
次要结局
- Degree of improvement in the mean CGI-S (global severity of the CGI scale) score at the end of study (8th week) as compared to baseline.(Baseline to week 8)
- Percentage of patients having a 50% reduction in the HAM-A total score at the end of the study (8th week) as compared to baseline