S 05985 combination versus AT1-Receptor Blocker/thiazide: a comparison of blood pressure lowering - efficacy and safety
| ISRCTN | ISRCTN61335805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61335805 |
| Clinical Trials Information System (CTIS) | 2006-005799-42 |
| Protocol serial number | CL3-05985-006 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 24/01/2008
- Registration date
- 29/02/2008
- 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 Neil Poulter
Scientific
Scientific
International Centre for Circulation Health
Imperial College London
59 North Wharf Road
London
W2 1PG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | International multicentre phase III randomised double-blind controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Perindopril Amlodipine Regimen versus AT1-Receptor Blocker/thiazide: a comparison of Blood pressure Lowering: Efficacy and Safety. A randomised, double blind, 9 month study of the efficacy and safety of four uptitrated doses of oral fixed combinations of perindopril/amlodipine, including a comparison with uptitrated doses of oral fixed combination of irbesartan and hydrochlorthiazide in mild to moderate hypertension. |
| Study objectives | To assess the efficacy of 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. Please note that as of 19/11/2012, Ireland and the Netherlands were added to the countries of recruitment. |
| Ethics approval(s) | Approval received from an English Ethics Committee on 30/09/2007 |
| Health condition(s) or problem(s) studied | Essential arterial hypertension |
| Intervention | S 05985 combination versus AT1-Receptor Blocker/ thiazide for 9 months |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | S 05985, thiazide |
| Primary outcome measure(s) |
1. Overall proportion of participants with controlled blood pressure (at 6 months) |
| Key secondary outcome measure(s) |
1. Efficacy versus comparator (at 6 months) |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 3000 |
| Key inclusion criteria | 1. Men or women 2. Over 18 years 3. Essential arterial hypertension |
| Key exclusion criteria | 1. Pregnancy, breast-feeding, childbearing potential without medically accepted method of contraception 2. Acute or chronic illness 3. Secondary hypertension 4. Malignant hypertension 5. Clinical symptomatic hypotension |
| Date of first enrolment | 05/12/2007 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
- Ireland
- Netherlands
Study participating centre
International Centre for Circulation Health
London
W2 1PG
United Kingdom
W2 1PG
United Kingdom
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 www.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 | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Poster results | results in poster | 01/06/2015 | 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 and poster presentation details added.
