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 ongoing treatment.
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
Treatment
Patient information sheet
Not available in web format, please use the contact details 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
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 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 statement:
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.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-06593-005_synopsis_report.pdf
Publication summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28181192