Condition category
Circulatory System
Date applied
24/01/2008
Date assigned
29/02/2008
Last edited
18/04/2018
Prospective/Retrospective
Retrospectively 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 Neil Poulter

ORCID ID

Contact details

International Centre for Circulation Health
Imperial College London
59 North Wharf Road
London
W2 1PG
United Kingdom

Additional identifiers

EudraCT number

2006-005799-42

ClinicalTrials.gov number

Protocol/serial number

CL3-05985-006

Study information

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.

Acronym

Study hypothesis

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

Approval received from an English Ethics Committee on 30/09/2007

Study design

International multicentre phase III randomised double-blind controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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

S 05985 combination versus AT1-Receptor Blocker/ thiazide for 9 months

Intervention type

Drug

Phase

Phase III

Drug names

S 05985, thiazide

Primary outcome measures

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 trial start date

05/12/2007

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men or women
2. Over 18 years
3. Essential arterial hypertension

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3000

Participant 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

Recruitment start date

05/12/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Ireland, Netherlands, United Kingdom

Trial participating centre

International Centre for Circulation Health
London
W2 1PG
United Kingdom

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 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.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

http://clinicaltrials.servier.com/wp-content/uploads/CL3-05985-006_synopsis_report.pdf

Publication summary

2015 results in poster in http://journals.lww.com/jhypertension/Abstract/2015/06001/PP_07_17___A_RANDOMIZED,_DOUBLE_BLIND_STUDY_OF_THE.580.aspx`

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 poster presentation details added.