Comparison of blood pressure lowering effect of drugs.

Phase 4

Recruiting

Conditions: Hypertension

Registration Number: CTRI/2017/09/009725

Lead Sponsor: Indira Gandhi Medical College

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 134

Inclusion Criteria

1.Newly detected hypertensive patients with BP of â‰¥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.

Exclusion Criteria

Patients age <18 years and >80 years 2.
Pregnancy & Lactating females 3.
Renal or Hepatic disease 4.
Congestive heart disease 5.
Established CAD with and without MI 6.
History of CVA & PVD 8.
Patient unwilling to participate in the study 8.
Elevation in BP >180/110 during withdrawal of antihypertensive drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the difference in Mean Systolic blood pressure and Diastolic blood pressure between Fixed dose combination group and Free drug combination group	2 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Indira Gandhi Medical College
🇮🇳
Shimla, HIMACHAL PRADESH, India
Indira Gandhi Medical College
🇮🇳Shimla, HIMACHAL PRADESH, India
Dr Prakash Chand Negi
Principal investigator
9418103709
negiprakash59@gmail.com