Additional identifiers
EudraCT/CTIS number
2010-020945-28
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL3-05985-018
Study information
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
Acronym
Study hypothesis
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
Study design
International multicentre phase III randomised double blind open controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Perindopril arginine, amlodipine, valsartan
Primary outcome measure
1. Efficacy of S 05985 combination versus comparator in blood pressure lowering
2. Safety assessment of treatments
Secondary outcome measures
1. Efficacy of both combination strategies on ABPM parameters
2. Long-term safety assessment of S 05985 combination (14 months)
Overall study start date
06/11/2010
Overall study end date
01/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Outpatients
2. Men or women
3. Aged 18 years old at least
4. Mild to moderate hypertensive patient
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
1600
Participant 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
Recruitment start date
06/11/2010
Recruitment end date
01/09/2012
Locations
Countries of recruitment
Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Korea, South, Latvia, Lithuania, Mexico, Netherlands, Portugal, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom
Study participating centre
Ospedale S. Gerardo
Monza
20052
Italy
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
Individual participant data (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.
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/02/2015 | Yes | No |