Comparing Telmisartan Administration Regimens for Stage 1 Hypertension Treatment Morning Bedtime and Split Dose Approaches
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- compare the efficacy of telmisartan in controlling the 24-hour mean systolic blood pressure and diastolic blood pressure after 12 weeks of administration as a single morning dose a single bedtime dose and divided morning and bedtime doses
研究概览
简要总结
study will involve newly diagnosed hypertension patients with systolic blood pressure between 140 and 159 mm Hg and diastolic blood pressure between 90 to 99 mm Hg who meet the inclusion and exclusion criteria and provide informed consent It is a 12 week duration study with patient follow up conducted at the end of 12 weeks Efficacy parameters will be assessed at baseline and at the end of the studyParameters measured will include systolic blood pressure diastolic blood pressure and heart rate Measurements will be taken using a 48 hour ABPM device at baseline and at the end of the study ABPM will automatically record SBP DBP and HR every 20 minutes from 7 am to 11 pm and every 30 minutes at night for 48 hours Blood samples will be collected at the initiation and end of the study to assess fasting glucose urea creatinine cholesterol and triglyceride levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 18 to 65 years Newly diagnosed cases of Stage 1 hypertension Patients willing to undergo Ambulatory Blood Pressure Monitoring ABPM and Automatic Office Blood Pressure AOBP measurement.
排除标准
- •Shift workers Heavy drinkers intake and gt 80 gm per day Heavy smokers 20 cigarettes per day Patients with Type 1 diabetes mellitus Patients with a history of cardiovascular disorders like unstable angina heart failure arrhythmia, myocardial infarction, and coronary revascularization Patients with a history of stroke Patients with impaired kidney function Pregnant women Patients using non-steroidal anti-inflammatory drugs (NSAIDs) regularly.
结局指标
主要结局
compare the efficacy of telmisartan in controlling the 24-hour mean systolic blood pressure and diastolic blood pressure after 12 weeks of administration as a single morning dose a single bedtime dose and divided morning and bedtime doses
时间窗: compare the efficacy of telmisartan in controlling the 24-hour mean systolic blood pressure and diastolic blood pressure after 12 weeks of administration as a single morning dose a single bedtime dose and divided morning and bedtime doses
次要结局
- compare the efficacy of telmisartan in controlling the mean diurnal SBP and DBP when administered as a single morning dose a single bedtime dose and divided morning and bedtime doses after 12 weeks(Baseline and at 12 weeks)
- compare the efficacy of telmisartan in controlling nocturnal mean SBP and mean DBP when administered as a single morning dose a single bedtime dose and divided morning and bedtime doses after 12 weeks(Baseline and after 12 weeks)
- compare the impact of telmisartan on fasting blood glucose creatinine(uric acid, cholesterol and triglyceride levels when administered as a single morning dose a single bedtime dose and divided morning and bedtime doses)
- compare the safety profile including adverse drug reactions of telmisartan when administered as a single morning dose a single bedtime dose and divided(Morning and bedtime doses)
- compare the differential effects of telmisartan on extreme nocturnal blood pressure dipping patterns specifically focusing on risers individuals exhibiting higher nocturnal BP than daytime BP and extreme dippers individuals exhibiting a marked nocturnal BP decline when administered as a single morning dose a single bedtime dose and divided morning and evening doses(Baseline and after 12 weeks)
研究者
DR RIMPLE JEET KAUR
All India institute of medical sciences jodhpur