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

ISRCTN	ISRCTN16442558
DOI	https://doi.org/10.1186/ISRCTN16442558
Secondary identifying numbers	CL3-06593-005

Submission date: 14/09/2012
Registration date: 19/10/2012
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Valérie Fautrier
Scientific

Institut de Recherche Internationales Servier
50, rue Carnot
Suresnes
92284
France

Study information

Study design	International multicentre randomised open-label 12-week study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	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 ongoing treatment.
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Perindopril, Indapamide, Amlodipine
Primary outcome measure	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 study start date	01/01/2014
Completion date	01/09/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	150
Key inclusion criteria	1. Men or women of any ethnic origin > or = 18 years old 2. Uncontrolled hypertension
Key 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
Date of first enrolment	01/01/2014
Date of final enrolment	01/09/2014

Locations

Countries of recruitment

France
Russian Federation
Serbia

Study participating centre

Institut de Recherche Internationales Servier

Suresnes
92284
France

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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 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 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Results article	results	01/06/2017		Yes	No

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.
19/12/2017: results summary.
10/02/2017: Publication reference added.
02/04/2014: The following changes were made to the trial record: 1. The overall trial start date was changed from 01/10/2012 to 01/01/2014. 2. The overall trial end date was changed from 31/08/2013 to 01/09/2014.