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
| ISRCTN | ISRCTN63697536 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63697536 |
| Secondary identifying numbers | CL3-05520-005 |
- Submission date
- 27/03/2014
- Registration date
- 28/04/2014
- Last edited
- 18/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Sergey V. Nedogoda
Scientific
Scientific
State Institution of Higher Professional Education Volgograd State Medical University of Ministry of Health and Social Development of Russian Federation
Chair of therapy and endocrinology department of faculty of advanced education
1, Tsiolkovsky str.
Volgograd
400000
Russian Federation
Study information
| Study design | International multicentre randomised open-label - 12-weeks study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study hypothesis | To evaluate the clinical efficacy and safety of efficacy and safety study comparing the fixed combination of two antihypertensive agents, indapamide and amlodipine in a single-pill versus free dual monocomponents in patients having with mild to moderate uncontrolled essential hypertension. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Condition | Essential hypertension |
| Intervention | 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 total treatment duration is 12 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Indapamide and amlodipine |
| Primary outcome measure | Decrease of Office systolic blood pressure (SBP) (supine SBP value in mmHg, after 12 weeks) |
| Secondary outcome measures | 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 |
| Overall study start date | 24/05/2014 |
| Overall study end date | 31/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 24/05/2014 |
| Recruitment end date | 31/01/2015 |
Locations
Countries of recruitment
- Armenia
- Russian Federation
Study participating centre
State Institution of Higher Professional Education Volgograd State Medical University of Ministry of Health and Social Development of Russian Federation
Volgograd
400000
Russian Federation
400000
Russian Federation
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
"ROR" |
https://ror.org/034e7c066 |
|---|
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current version as of 28/03/2018: Summary results are published in https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature. 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 1st January 2014. Previous version as of 24/01/2018: Publication plan: All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study. |
| 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? |
|---|---|---|---|---|---|
| Basic results | No | No |
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.
04/12/2017: results summary added.
