A clinical trial to study the effects of two drugs, fixed dose combination capsules of Telmisartan & Indapamide (as sustained release) and Telmisartan tablets in patients with hypertension.

An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination capsules of Telmisartan & Indapamide (as sustained release) in comparison with Telmisartan tablets in patients suffering from hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000863

Enrollment

200

Registered

2010-01-06

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: I10- Essential (primary) hypertension Health Condition 2: null- Hypertension

Interventions

Intervention1: Fixed-dose combination capsules of Telmisartan 40 mg &amp

Indapamide 1.5 mg (as sustained release): Once in a day for 6 weeks Control Intervention1: Telmisartan 40 mg tablets: Once in a day for 6 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex more than or equal to 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial). 2. Patients with hypertension (defined as supine systolic and/or diastolic blood pressure more than 140 mm Hg and 90 mm Hg respectively) 3. Informed consent of the patient/relative

Exclusion criteria

Exclusion criteria: 1. Pregnancy and/or Lactation 2. Patients with anuria, progressive & severe oliguria, hepatic coma, hypokalaemia, hyponatremia, hypochloremia, volume depletion, hyperuricaemia, secondary hypertension, congestive heart failure, systemic lupus erythematosus. 3. Patients with hepatic and /or renal dysfunction or bilateral renal artery stenosis. 4. Patients with a history of known hypersensitivity to either Telmisartan or Indapamide or to other sulfonamide derivatives or to any other component of the study drugs 5. Patients with any other serious concurrent illness or malignancy 6. Patients with continuing history of alcohol and / or drug abuse 7. Participation in another clinical trial in the past 3 months

Design outcomes

Primary

Measure	Time frame
The degree of reduction in supine diastolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0)Timepoint: 2,4 & 6 weeks	—

Secondary

Measure	Time frame
The degree of reduction in supine systolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0)Timepoint: 2,4 & 6 weeks	—

Countries

India

Contacts

Public ContactDr Ravindra Mittal

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

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