Efficacy and safety of the S 05985 combination compared with each individual component: randomised, double-blind, placebo-controlled study over eight weeks in hypertensive patients
| ISRCTN | ISRCTN14235381 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14235381 |
| EudraCT/CTIS number | 2006-005797-44 |
| Secondary identifying numbers | CL2-05985-005 |
- Submission date
- 11/07/2007
- Registration date
- 23/01/2008
- Last edited
- 20/04/2020
- 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 Stéphane Laurent
Scientific
Scientific
Hôpital Européen Georges Pompidou
20-40 rue Leblanc
Paris
75908
France
Study information
| Study design | International multicentre phase II randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Efficacy and safety of the S 05985 combination compared with each individual component: randomised, double-blind, placebo-controlled study over eight weeks in hypertensive patients |
| Study objectives | Efficacy and safety assessment of the S 05985 combination compared with each individual component and placebo. |
| Ethics approval(s) | CPP Ile de France XI, Saint Germain en Laye (France), 15/02/2007, ref : 07005 |
| Health condition(s) or problem(s) studied | Essential arterial hypertension |
| Intervention | S 05985 versus each component given separately during 8 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | S 05985 |
| Primary outcome measure | Change in blood pressure measured before and after 2, 4 and 8 weeks |
| Secondary outcome measures | 1. Response to the treatment and normalisation of blood pressure 2. Safety Measured before and after 2, 4 and 8 weeks |
| Overall study start date | 15/05/2007 |
| Completion date | 15/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1500 |
| Total final enrolment | 1581 |
| Key inclusion criteria | 1. Men or women 2. 18 to 80 years 3. Essential uncomplicated mild to moderate hypertensive patients |
| Key exclusion criteria | 1. Very high cardiovascular risk patients 2. Severe disease 3. Pregnancy 4. Obesity 5. Secondary hypertension |
| Date of first enrolment | 15/05/2007 |
| Date of final enrolment | 15/07/2008 |
Locations
Countries of recruitment
- France
- Hungary
- Latvia
- Lithuania
- Russian Federation
- Ukraine
Study participating centre
Hôpital Européen Georges Pompidou
Paris
75908
France
75908
France
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 | Publication plan: Summary results are published in https://clinicaltrials.servier.com. |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | 20/04/2020 | No | No |
Editorial Notes
20/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
29/11/2017: Results summary added.
