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Register:	ISRCTN
Last refreshed on:	4 May 2020
Main ID:	ISRCTN14235381
Date of registration:	23/01/2008
Prospective Registration:	No
Primary sponsor:	Institut de Recherches Internationales Servier (France)
Public title:	Efficacy and safety of the S 05985 combination compared with each individual component: randomised, double-blind, placebo-controlled study over eight weeks in hypertensive patients
Scientific title:	Efficacy and safety of the S 05985 combination compared with each individual component: randomised, double-blind, placebo-controlled study over eight weeks in hypertensive patients
Date of first enrolment:	15/05/2007
Target sample size:	1500
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN14235381
Study type:	Interventional
Study design:	International multicentre phase II randomised double-blind placebo-controlled study (Treatment)
Phase:	Phase II

Countries of recruitment
France	Hungary	Latvia	Lithuania	Russian Federation	Ukraine

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Stéphane Laurent
Address:	Hôpital Européen Georges Pompidou 20-40 rue Leblanc 75908 Paris France
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Essential arterial hypertension
Circulatory System
Hypertension

Intervention(s)

S 05985 versus each component given separately during 8 weeks.

Primary Outcome(s)

Change in blood pressure measured before and after 2, 4 and 8 weeks

Secondary Outcome(s)

1. Response to the treatment and normalisation of blood pressure
2. Safety
Measured before and after 2, 4 and 8 weeks

Secondary ID(s)

2006-005797-44

CL2-05985-005

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	15/07/2008
URL:

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