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Comparison of blood pressure lowering effect of drugs.

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. - Anti-hypertensive drugs

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009725
Enrollment
134
Registered
2017-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Hypertension

Interventions

Intervention1: Fixed dose combination (FDC) ofTelmisartan(Angiotensin receptor blocker)and Amlodipine(Calcium channel blocker): Dose of FDC single tablet containing temisaratn 40 mg & Amlodipine 5 mg,

Sponsors

Indira Gandhi Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 3.Patients age between 18 to 80 years. 4.Willingness to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients age 80 years 2. Pregnancy & Lactating females 3. Renal or Hepatic disease 4. Congestive heart disease 5. Established CAD with and without MI 6. Known sensitivity to studied drugs 7. History of CVA & PVD 8. Patient unwilling to participate in the study 8. Elevation in BP >180/110 during withdrawal of antihypertensive drugs

Design outcomes

Primary

MeasureTime frame
To compare the difference in Mean Systolic blood pressure and Diastolic blood pressure between Fixed dose combination group and Free drug combination groupTimepoint: 2 months

Secondary

MeasureTime frame
1.Change between groups in proportion of patient achieving target blood pressure 2.Percentage reduction in Systolic and diastolic blood pressure from baseline blood pressureTimepoint: 2 months

Countries

India

Contacts

Public ContactDr Prakash Chand Negi

Indira Gandhi Medical College and Hospital

sharmanavdha7@gmail.com9818848787

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026