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
EudraCT/CTIS number	2010-020945-28
Secondary identifying numbers	CL3-05985-018

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

Ospedale S. Gerardo
1 Divisione di Medicina
Via Donizetti, 106
Monza
20052
Italy

Study information

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
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
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
Completion date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Belgium
Brazil
Canada
Czech Republic
France
Germany
Italy
Korea, South
Latvia
Lithuania
Mexico
Netherlands
Portugal
Russian Federation
Singapore
Spain
Taiwan
Türkiye
United Kingdom

Study participating centre

Ospedale S. Gerardo

Monza
20052
Italy

Sponsor information

Institut de Recherches Internationales Servier (France)
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	No
IPD sharing plan summary	Not provided at time of registration
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.
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?
Basic results				No	No
Results article	results	01/02/2015		Yes	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 publication reference added.
30/09/2016: Internal review