CandeSpartan Study Candesartan Spanish Response-prediction and Tolerability Study Observational Study on Response Predictors and Tolerability of Candesartan in Usual Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Response prediction.
研究概览
简要总结
Observational, prospective, descriptive, open study on response predictors and tolerability of Candesartan in patients >18 years with episodic or chronic migraine with prior failure of three or more preventive drugs. Patients will receive Candesartan the same manner and intensity if they were not enrolled in the study. Vital signs, clinical variables and adverse events will be monitored.
Primary endpoint will be to determine demographic and clinical factors associated with a 50% reduction in the frequency of headache days per month between weeks 20 and 24 compared with baseline.
详细描述
CandeSpartan Study Candesartan Spanish Response-prediction and Tolerability study
Observational study on response predictors and tolerability of Candesartan in usual clinical practice
INTRODUCTION:
Migraine is a neurological disease with a prevalence of 14% of the population 1, 2. It is the second most disabling disease in terms of years of life lived with disability, especially in the age group between 15 and 49 years3. Migraine is also the headache the most frequently seen in neurology consultations and headache units4.
Since the 1970s, numerous preventive drugs have been developed. One of the problems is that many of these drugs come from other indications, such as depression, epilepsy or hypertension5. Nowadays, clinical practice guidelines base the indication mainly on the level of evidence6, which, given the age and scarcity of these studies, is limited. Although the new drugs are based on clinical trials according to the current methodology, they are unlikely to be indicated in patients who have not tried any preventive treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Migraine patients
干预措施: Candesartan (Drug)
结局指标
主要结局
Response prediction.
时间窗: Weeks 20 to 24 compared with baseline period
To determine which demographic or clinical variables present at baseline are associated with a 50% reduction in the frequency of headache days per month between weeks 20 to 24 compared with baseline in a regression analysis.
次要结局
- Response predictors(Between weeks 20 to 24 compared with baseline period)
- Intense headache days reduction at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- Acute headache medication reduction at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- Headache days reduction at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- Intense headache days reduction at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- Adverse events.(through study completion, an average of 24 weeks.)
- 50% response rate at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- Discontinuation due to adverse events.(through study completion, an average of 24 weeks.)
- Change in heart rate at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- Change in heart rate at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- Change in systolic blood pressure at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- Change in systolic blood pressure at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- Change in diastolic blood pressure at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- Change in HIT-6 scale at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- 30% response rate at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- 100% response rate at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- 50% response rate at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- Headache days reduction at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- 75% response rate at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- 30% response rate at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- 75% response rate at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- 100% response rate at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- Acute headache medication reduction at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- Change in HIT-6 scale at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- Change in HADS scale at 24 weeks(Between weeks 20 to 24 compared with baseline period)
- Change in HADS scale at 12 weeks(Between weeks 8 to 12 compared with baseline period)
- Change in diastolic blood pressure at 24 weeks(Between weeks 20 to 24 compared with baseline period)
研究者
David García Azorín
Principal investigator
Hospital Clínico Universitario de Valladolid