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 |
| EudraCT/CTIS number | 2006-005799-42 |
| Secondary identifying numbers | CL3-05985-006 |
- 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
| Study design | International multicentre phase III randomised double-blind controlled 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 | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | S 05985, thiazide |
| Primary outcome measure | 1. Overall proportion of participants with controlled blood pressure (at 6 months) 2. Safety assessment |
| Secondary outcome measures | 1. Efficacy versus comparator (at 6 months) 2. New onset of clinical events or condition of special interest |
| Overall study start date | 05/12/2007 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- Ireland
- Netherlands
- United Kingdom
Study participating centre
International Centre for Circulation Health
London
W2 1PG
United Kingdom
W2 1PG
United Kingdom
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"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 www.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 www.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 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 | |||
| 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.
