S 05985 combination versus angiotensin II receptor blocker/calcium channel blocker: a comparison of blood pressure lowering - efficacy and safety
| ISRCTN | ISRCTN59214686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59214686 |
| Clinical Trials Information System (CTIS) | 2010-020945-28 |
| Protocol serial number | CL3-05985-018 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 02/09/2010
- Registration date
- 25/10/2010
- 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 of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof G. Mancia
Scientific
Scientific
Ospedale S. Gerardo
1 Divisione di Medicina
Via Donizetti, 106
Monza
20052
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | International multicentre phase III randomised double blind open controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Perindopril arginine/amlodipine versus valsartan/amlodipine antihypertensive strategies: efficacy and safety in mild to moderate hypertensive patients - a randomised, double-blind 6-month study followed by 8-month open label long-term follow-up with perindopril arginine/amlodipine |
| Study objectives | To evaluate the efficacy on blood pressure lowering and the safety of increasing doses of the S 05985 combination and to compare these effects with those of another commonly used antihypertensive drug combination at different doses. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Essential arterial hypertension |
| Intervention | One oral or two capsules per day of: 1. S 05985 combination over a maximum duration of 14 months or 2. Angiotensin II receptor blocker/calcium channel blocker over a maximum duration of 6 months |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Perindopril arginine, amlodipine, valsartan |
| Primary outcome measure(s) |
1. Efficacy of S 05985 combination versus comparator in blood pressure lowering |
| Key secondary outcome measure(s) |
1. Efficacy of both combination strategies on ABPM parameters |
| Completion date | 01/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1600 |
| Key inclusion criteria | 1. Outpatients 2. Men or women 3. Aged 18 years old at least 4. Mild to moderate hypertensive patient |
| Key exclusion criteria | 1. Pregnancy or breastfeeding women 2. Secondary hypertension 3. Any patient suffering from an acute or chronic illness 4. Contraindication to any study treatments |
| Date of first enrolment | 06/11/2010 |
| Date of final enrolment | 01/09/2012 |
Locations
Countries of recruitment
- United Kingdom
- Belgium
- Brazil
- Canada
- Czech Republic
- France
- Germany
- Italy
- Korea, South
- Latvia
- Lithuania
- Mexico
- Netherlands
- Portugal
- Russian Federation
- Singapore
- Spain
- Taiwan
- Türkiye
Study participating centre
Ospedale S. Gerardo
Monza
20052
Italy
20052
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| 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 | 01/02/2015 | 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.
04/12/2017: results summary and publication reference added.
30/09/2016: Internal review
