Condition category
Circulatory System
Date applied
14/09/2012
Date assigned
19/10/2012
Last edited
02/04/2014
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

Mrs Valérie Fautrier

ORCID ID

Contact details

Institut de Recherche Internationales Servier
50
rue Carnot
Suresnes
92284
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-06593-005

Study information

Scientific title

Evaluation of the clinical efficacy and safety of Perindopril / Indapamide / Amlodipine fixed-dose combination in single-pill versus free dual therapy at the same dose as the single-pill combination in patients with uncontrolled essential hypertension

Acronym

Study hypothesis

To evaluate the clinical efficacy and safety of fixed-dose combination Perindopril / Indapamide / Amlodipine in single-pill versus free dual therapy in patients having an uncontrolled hypertension under on-going treatment.

On 02/04/2014 the following changes were made to the trial record:
1. The anticipated start date was changed from 01/10/2012 to 01/01/2014.
2. The anticipated end date was changed from 31/08/2013 to 01/09/2014.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

International multicentre randomised open-label 12-week study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Essential hypertension

Intervention

One treatment period: Single-pill combination of Perindopril / Indapamide / Amlodipine versus free dual therapy by fixed dose combination of Perindopril / Indapamide and by Amlodipine

Intervention type

Drug

Phase

Not Applicable

Drug names

Perindopril, Indapamide, Amlodipine

Primary outcome measures

1. Supine systolic blood pressure (SBP) and diastolic blood pressure (DBP): Change from baseline to last post-baseline assessment
2. Supine blood pressure normalisation

Secondary outcome measures

1. Supine and standing SBP and DBP : Change from baseline to last post-baseline assessment
2. Supine and standing blood pressure normalisation : at the last post-baseline assessment for each visit measurement
3. Adverse events
4. Blood and urine biochemistry
5. Haematology
6. Vital signs and physical examination
7. 12-lead electrocardiogram

Overall trial start date

01/01/2014

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men or women of any ethnic origin > or = 18 years old
2. Uncontrolled hypertension

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study
2. Hypertension known to be resistant to diuretics or ACE inhibitors
3. Secondary hypertension
4. Complicated hypertension
5. Obesity
6. History of renal disease, ventricular rhythm disorders, atrial fibrillation, atrial flutter
7. Diabetes
8. Grapefruit juice is forbidden during the study

Recruitment start date

01/01/2014

Recruitment end date

01/09/2014

Locations

Countries of recruitment

Russian Federation, Serbia

Trial participating centre

Institut de Recherche Internationales Servier
Suresnes
92284
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