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
| ISRCTN | ISRCTN16442558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16442558 |
| Protocol serial number | CL3-06593-005 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 14/09/2012
- Registration date
- 19/10/2012
- Last edited
- 18/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
Institut de Recherche Internationales Servier
50, rue Carnot
Suresnes
92284
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | International multicentre randomised open-label 12-week study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study objectives | To evaluate the clinical efficacy and safety of fixed-dose combination Perindopril / Indapamide / Amlodipine in single-pill versus free dual therapy in patients having an uncontrolled hypertension under ongoing treatment. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Essential hypertension |
| Intervention | One treatment period: Single-pill combination of Perindopril / Indapamide / Amlodipine versus free dual therapy by fixed dose combination of Perindopril / Indapamide and by Amlodipine |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Perindopril, Indapamide, Amlodipine |
| Primary outcome measure(s) |
1. Supine systolic blood pressure (SBP) and diastolic blood pressure (DBP): Change from baseline to last post-baseline assessment |
| Key secondary outcome measure(s) |
1. Supine and standing SBP and DBP: Change from baseline to last post-baseline assessment |
| Completion date | 01/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Men or women of any ethnic origin > or = 18 years old 2. Uncontrolled hypertension |
| Key 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 |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 01/09/2014 |
Locations
Countries of recruitment
- France
- Russian Federation
- Serbia
Study participating centre
92284
France
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2017 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/04/2018: Internal review
28/03/2018: The publication and dissemination plan has been changed.
24/01/2018: Publication plan and IPD sharing statement added.
19/12/2017: results summary.
10/02/2017: Publication reference added.
02/04/2014: The following changes were made to the trial record: 1. The overall trial start date was changed from 01/10/2012 to 01/01/2014. 2. The overall trial end date was changed from 31/08/2013 to 01/09/2014.
