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 hypertensio

Not Applicable

Completed

• Conditions: Essential hypertension; Circulatory System; Hypertension

• Registration Number: ISRCTN16442558
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28181192

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-19
• Study Completion: 2014-09-01
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Supine systolic blood pressure (SBP) and diastolic blood pressure (DBP): Change from baseline to last post-baseline assessment<br>2. Supine blood pressure normalisation

Secondary Outcome Measures

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