A clinical study to evaluate the safety and efficacy of FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg tablet in mild, moderate and severe hypertensive patients.

A phase III, multicenter, open label, single treatment clinical study to evaluate the safety and efficacy of FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg tablet in mild, moderate and severe hypertensive patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000122

Enrollment

200

Registered

2010-03-25

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: I159- Secondary hypertension, unspecified

Interventions

Intervention1: Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg: Orally once daily for 12 weeks Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: -Written informed consent from the patient. -Male and female patients with age above 18 years inclusive. -Diagnosis of mild, moderate & severe hypertensive patients with or without concomitant diabetes. -Patients who will be uncontrolled on monotherapy with or without diabetes mellitus will be included in this study.

Exclusion criteria

Exclusion criteria: -Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion. -Known or suspected secondary hypertension. -Patient with history of asthma or angina. -Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding. -Known hypersensitivity to Telmisartan, Amlodipine and Hydrochlorthiazide. -Patient who is consuming/ has received drugs, which have interaction with Telmisartan, Amlodipine and Hydrochlorthiazide, during last 14 days. -Participation in any other clinical trial during last 30 days.

Design outcomes

Primary

Measure	Time frame
Reduction in blood pressure for FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg TabletTimepoint: 12 weeks	—

Secondary

Measure	Time frame
Percentage of patients with significant reduction in blood pressure of FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg TabletTimepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com09825585119

Outcome results

None listed

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