An Open label Multicenter Non Interventional Observational Study to Evaluate Efficacy of Telmisartan 80 mg Amlodipine 10 mg or 5mg and Chlorthalidone 12.5 mg compared to continuation of Telmisartan 80 mg and Amlodipine 10 mg or 5mg Dual therapy in Hypertensive patients not responding to four weeks of Telmisartan 80 mg and Amlodipine 10 mg or 5mg Dual Combination therapy
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- Change from baseline in mean Seated trough DBP (Week 12)
研究概览
简要总结
Background :
Hypertension poses a severe health risk to the Indian population. The prevalence of hypertension is on the rise in India and Worldwide. This study is planned as post marketing non-interventional observational study to be conducted in India to assess to assess efficacy and safety of Telmisartan 80 mg + Amlodipine 10 mg/ 5mg + Chlorthalidone 12.5 mg in hypertensive patients not responding to four weeks of therapy with Telmisartan 80 mg + Amlodipine 10 mg/ 5mg. The efficacy and safety for the treatment regimen of Telmisartan + Amlodipine dual combination therapy has been well established through enough clinical evidence. The combination is widely prescribed by the physicians. However there are cases where the patient does not respond to the treatment regimen and target blood pressure ranges are not reached even though the patient adheres to the treatment regimen prescribed by the physician. This may be due to inadequate treatment regimen. This becomes a problem for the patient as well as the physician, as uncontrolled blood pressure leads to other high risk complications (CVD‟s, chronic kidney disease etc.,). Such kind of non responder patient population prevalence is on the rise in India. Considering the rise in prevalence of hypertension in India and also rise in treatment non responders an alternative treatment regimen might be warranted. Our objective is to assess the efficacy and safety of Telmisartan 80 mg + Amlodipine 10 mg/ 5mg + Chlorthalidone 12.5 mg triple drug combination for effective management of stage II hypertension in patients who are not responding to four weeks of dual therapy with Telmisartan 80 mg + Amlodipine 10 mg/ 5mg.
Primary objective: To evaluate efficacy of Telmisartan 80 mg + Amlodipine 10 mg/ 5mg + Chlorthalidone 12.5 mg in hypertensive patients not responding to four weeks of dual therapy with Telmisartan 80 mg + Amlodipine 10 mg/ 5mg
Secondary objective: To evaluate safety of Telmisartan 80 mg + Amlodipine 10 mg/ 5mg + Chlorthalidone 12.5 mg in hypertensive patients not responding to four weeks of dual therapy with Telmisartan 80 mg + Amlodipine 10 mg/ 5mg
Cohort 1*: Telmisartan 80 mg + Amlodipine 5 mg/10 mg + Chlorthalidone 12.5 mg Cohort 2: Telmisartan 80 mg + Amlodipine 5 mg/10 mg *Patients not responding to Telmisartan 80 mg + Amlodipine 5 mg/10 mg dual therapy to receive triple therapy with corresponding dose of Telmisartan and Amlodipine. No provision of increasing dose of patients initiated on Telmisartan 80 mg + Amlodipine 5 mg to Telmisartan 80 mg + Amlodipine 10 mg
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female treatment naïve patients, aged 18–80 years, with diagnosis of Stage II essential hypertension (DBP 100–114 mm Hg and SBP 160–199mm Hg) at entry, who are considered appropriate for initial dual therapy with Telmisartan 80 mg+ Amlodipine 5mg/ 10 mg
- •Patients who have inadequate blood pressure control (DBP >90 mm Hg) but have shown atleast 2 mm DBP reduction after 4 weeks of dual therapy will be selected for treatment allocation of triple therapy or dual therapy NOTE –patients with initial DBP of 100-109mmHg generally initiated on telmisartan 80 mg + Amlodipine 5mg and those with DBP 110-114 mm Hg initiated on telmisartan 80 Mg + amlodipine 10mg.
排除标准
- •Patients already taking antihypertensive drugs at screening (since the study is intended to enroll treatment naïve patients) 2.Patients not ready to refrain from taking treatment with other drugs that could interfere with the evaluation of efficacy and tolerability.
- •3.Patients with secondary hypertension (eg.
- •due to renal artery stenosis etc.) 4.Patients with uncontrolled diabetes mellitus, significant cardiovascular or cerebrovascular disease [congestive heart failure (New York Heart Association class III/IV); unstable angina in the previous 3 months; stroke within the previous 6 months; myocardial infarction, cardiac surgery, or percutaneous transluminal coronary angiography in the previous 3 months; cardiac arrhythmia; cardiomyopathy; aortic or mitral valve stenosis] 5.Patients with renal or hepatic disease (based on known history or lab abnormalities) or serum electrolyte abnormalities.
结局指标
主要结局
Change from baseline in mean Seated trough DBP (Week 12)
时间窗: Change from baseline in mean Seated trough DBP (Week 12)
次要结局
- Change from baseline in(ï‚· Mean Seated trough SBP (Week 12))