Condition category
Circulatory System
Date applied
02/09/2010
Date assigned
25/10/2010
Last edited
18/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof G. Mancia

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2010-020945-28

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

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

Trial setting

Other

Trial 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

Phase

Phase III

Drug names

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 trial start date

06/11/2010

Overall trial 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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.servier.com/

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.

IPD sharing statement:
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.

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

http://clinicaltrials.servier.com/wp-content/uploads/CL3-05985-018_synopsis_report.pdf

Publication list

2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25380149

Publication citations

Additional files

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