A clinical study to evaluate the effects of Fixed Dose Combination of 2 drugs, Indapamide S.R. (1.5 mg) + Amlodipine (5 mg) in patients with high blood pressure

Efficacy and Tolerability of Fixed Dose Combination of Indapamide S.R. (1.5 mg) + Amlodipine (5 mg) in patients suffering from stage II/III hypertension

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000114

Enrollment

240

Registered

2010-03-04

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- Stage II/ III hypertension

Interventions

Intervention1: Indapamide S.R. (1.5 mg) + Amlodipine (5 mg): 1 tablet daily Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed untreated hypertensive patients having a baseline blood pressure > 160/100 mmHg) OR 2. Uncontrolled patients of hypertension with a baseline blood pressure > 140/90 mmHg on monotherapy with a Calcium Channel Blocker (CCB) 3. Patients of either sex 4. With confirmed diagnosis of Stage II/ III (moderate to severe) hypertension, as per JNC 7 guidelines

Exclusion criteria

Exclusion criteria: 1) Uncontrolled diabetes 2) H/o myocardial infarction within the previous 3 months 3) H/o cerebrovascular event within previous 3 months 4) Uncontrolled arrhythmias 5) H/o Heart failure 6) Patients with severe impaired renal function serum creatinine levels > 5.3 mg/dl and / or serious liver disorders 7) Patients unwilling to give informed consent. 8) Patients with history of hypersensitivity to Indapamide or Amlodipine 9) Any contraindication to Thiazide type diuretic and/or CCB 10) Pregnancy or lactation 11) Patients with any other condition or disease, which in opinion of the investigator could preclude evaluation of response to study medication or hamper the safety of the trial participant. 12) Patients previously enrolled in similar trial in the last 6 months

Design outcomes

Primary

Measure	Time frame
To assess the blood pressure reduction rates in moderate to severe hypertensive patients after treatment with an FDC (Indapamide S.R. 1.5 mg + Amlodipine 5 mg) given once daily in the morning during the study evaluation periodTimepoint: Day 0, Day 15, Day 30 & Day 45	—

Secondary

Measure	Time frame
To access the safety and tolerability of Indapamide S.R. 1.5 mg + Amlodipine 5 mgTimepoint: Day 0, Day 15, Day 30 & Day 45	—

Countries

India

Contacts

Public ContactDr. Manjusha Rajarshi

manjusha.rajarshi@in.netgrs.com02224162727

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 20, 2026