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临床试验/CTRI/2017/09/009725
CTRI/2017/09/009725招募中4 期

To compare the antihypertensive effect of Fixed dose drug combination Telmisartan and Amlodipine versus Telmisartan and Amlodipine given individually in hypertensive patients - a randomized controlled study.

Indira Gandhi Medical College1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2015年6月7日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
134
试验地点
1
主要终点
To compare the difference in Mean Systolic blood pressure and Diastolic blood pressure between Fixed dose combination group and Free drug combination group

研究概览

简要总结

Hypertension is the leading risk factor for cardiovascular event (CVE).The substantial proportion of the hypertensive patients  are unaware of being hypertensive and among hypertensive patients large proportion are not taking antihypertensive medications, and less than one-third of patients taking hypertensive treatment reach the desired goal of <140/90 mm Hg. The reasons for poor compliance for antihypertensive medications viz unaffordability, non- availability, number of medications prescribed, lack of awareness about importance of keeping BP under control.Thus, there could be role of formulating a fixed drug combination polypill that may lower the cost and number of medications to be taken by the patient and thus improve the compliance.However, there could be a concern regarding drug stability, potency, efficacy, interactions of the drugs combined in the formulations.There are number of pharmaceutical firms manufacturing fixed drug combination with questionable drug potency, efficacy and stability of the formulation.There are studies comparing the antihypertensive efficacy of fixed drug combination with only one of the component of polypill. But there is no study done which compare the antihypertensive efficacy of fixed drug dose combination with both the component of polypill given at similar doses.Thus, the present study aims to assess the antihypertensive efficacy of fixed drug combination Telmisartan 40 mg and Amlodipine 5 mg with free drugs Telmisartan 40 mg and Amlodipine 5 mg used in hypertensive patients.

RECRUITEMENT STATUS - Till date, we recruited 99 patients , out of which 88 completed their 2 months of intervention. Remaining 35 patients will be recruited with in 2-3 months.

研究设计

研究类型
Interventional
分配方式
Stratified randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •1.Newly detected hypertensive patients with BP of ≥160/100 mm Hg 2.Established hypertensive; off drug for one week with BP >160/100 to <180/110 mm Hg. 3.Patients age between 18 to 80 years.
  • •4.Willingness to participate in the study.

排除标准

  • •Patients age <18 years and >80 years
  • •Pregnancy & Lactating females
  • •Renal or Hepatic disease
  • •Congestive heart disease
  • •Established CAD with and without MI
  • •History of CVA & PVD
  • •Patient unwilling to participate in the study
  • •Elevation in BP >180/110 during withdrawal of antihypertensive drugs.

结局指标

主要结局

To compare the difference in Mean Systolic blood pressure and Diastolic blood pressure between Fixed dose combination group and Free drug combination group

时间窗: 2 months

次要结局

  • 1.Change between groups in proportion of patient achieving target blood pressure(2.Percentage reduction in Systolic and diastolic blood pressure from baseline blood pressure)

研究者

申办方类型
Government medical college

研究点 (1)

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