Condition category
Circulatory System
Date applied
11/07/2007
Date assigned
23/01/2008
Last edited
13/08/2014
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 Stéphane Laurent

ORCID ID

Contact details

Hôpital Européen Georges Pompidou
20-40 rue Leblanc
Paris
75908
France

Additional identifiers

EudraCT number

2006-005797-44

ClinicalTrials.gov number

Protocol/serial number

CL2-05985-005

Study information

Scientific title

Acronym

Study hypothesis

Efficacy and safety assessment of the S 05985 combination compared with each individual component and placebo.

Ethics approval

CPP Ile de France XI, Saint Germain en Laye (France), 15/02/2007, ref : 07005

Study design

International multicentre phase II randomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

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 versus each component given separately during 8 weeks.

Intervention type

Drug

Phase

Phase II

Drug names

S 05985

Primary outcome measures

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 trial start date

15/05/2007

Overall trial end date

15/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men or women
2. 18 to 80 years
3. Essential uncomplicated mild to moderate hypertensive patients

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1500

Participant exclusion criteria

1. Very high cardiovascular risk patients
2. Severe disease
3. Pregnancy
4. Obesity
5. Secondary hypertension

Recruitment start date

15/05/2007

Recruitment end date

15/07/2008

Locations

Countries of recruitment

France, Hungary, Latvia, Lithuania, Russian Federation, Ukraine

Trial participating centre

Hôpital Européen Georges Pompidou
Paris
75908
France

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes