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Evaluation of the clinical efficacy and safety of Perindopril / Indapamide / Amlodipine fixed-dose combination in single-pill versus free dual therapy at the same dose as the single-pill combination in patients with uncontrolled essential hypertension

Evaluation of the clinical efficacy and safety of Perindopril / Indapamide / Amlodipine fixed-dose combination in single-pill versus free dual therapy at the same dose as the single-pill combination in patients with uncontrolled essential hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16442558
Enrollment
150
Registered
2012-10-19
Start date
2014-01-01
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 Hypertension

Interventions

One treatment period: Single-pill combination of Perindopril / Indapamide / Amlodipine versus free dual therapy by fixed dose combination of Perindopril / Indapamide and by Amlodipine

Sponsors

Institut de Recherches Internationales Servier (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men or women of any ethnic origin > or = 18 years old 2. Uncontrolled hypertension

Exclusion criteria

Exclusion criteria: 1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study 2. Hypertension known to be resistant to diuretics or ACE inhibitors 3. Secondary hypertension 4. Complicated hypertension 5. Obesity 6. History of renal disease, ventricular rhythm disorders, atrial fibrillation, atrial flutter 7. Diabetes 8. Grapefruit juice is forbidden during the study

Design outcomes

Primary

MeasureTime frame
1. Supine systolic blood pressure (SBP) and diastolic blood pressure (DBP): Change from baseline to last post-baseline assessment 2. Supine blood pressure normalisation

Secondary

MeasureTime frame
1. Supine and standing SBP and DBP: Change from baseline to last post-baseline assessment 2. Supine and standing blood pressure normalisation at the last post-baseline assessment for each visit measurement 3. Adverse events 4. Blood and urine biochemistry 5. Haematology 6. Vital signs and physical examination 7. 12-lead electrocardiogram

Countries

Russian Federation, Serbia

Outcome results

None listed

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