An efficacy and safety study comparing the fixed combination of two antihypertensive agents, indapamide and amlodipine in a single-pill, to the same drugs given separately, in patients with mild to moderate uncontrolled essential hypertension

Safety and efficacy of fixed dose combination of Indapamide SR / Amlodipine in single-pill versus free dual therapy at the same dose over 12-week of treatment, with conditional titration based on the blood pressure control, in patients with mild to moderate uncontrolled essential hypertension: an international, multicentre, randomised, open-label study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63697536

Enrollment

150

Registered

2014-04-28

Start date

2014-05-24

Completion date

Unknown

Last updated

2018-05-21

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

Conditions

Essential hypertension Circulatory System Essential (primary) hypertension

Interventions

Single-pill combination of Indapamide SR 1.5mg/ Amlodipine 5mg versus free dual therapy. At Week 6, the patient can be uptitrated to Indapamide SR 1.5mg/ Amlodipine 10mg versus free dual therapy. The

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men or women of any ethnic origin, 18 years or older 2. Mild to moderate essential combined systolic and diastolic hypertension or isolated systolic hypertension

Exclusion criteria

Exclusion criteria: 1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study 2. Orthostatic hypotension 3. Hypertension known to be resistant to diuretics and calcium channel inhibitors (given separately or in combination) 4. Secondary hypertension 5. Complicated hypertension 6. Diabetes mellitus type I and type II under treatment 7. Any history or known severe disease likely to interfere with the conduct of the study

Design outcomes

Primary

Measure	Time frame
Decrease of Office systolic blood pressure (SBP) (supine SBP value in mmHg, after 12 weeks)	—

Secondary

Measure	Time frame
1. SBP, diastolic blood pressure (DBP) and derivate parameters decrease after 12 weeks 2. Response to treatment and normalization of BP after 12 weeks 3. Home Blood Pressure Monitoring (HBPM) parameters efficacy after 12 weeks (HBPM device) 4. Safety of investigational drug products	—

Countries

Armenia, Russian Federation

Outcome results

None listed

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