Condition category
Circulatory System
Date applied
27/03/2014
Date assigned
28/04/2014
Last edited
18/04/2018
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

Prof Sergey V. Nedogoda

ORCID ID

Contact details

State Institution of Higher Professional Education “Volgograd State Medical University of Ministry of Health and Social Development of Russian Federation”
Chair of therapy and endocrinology department of faculty of advanced education
1
Tsiolkovsky str.
Volgograd
400000
Russian Federation

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-05520-005

Study information

Scientific title

Safety and efficacy of fixed dose combination of Indapamide SR / Amlodipine in single-pill versus free dual therapy at the same dose over 12-week of treatment, with conditional titration based on the blood pressure control, in patients with mild to moderate uncontrolled essential hypertension: an international, multicentre, randomised, open-label study

Acronym

Study hypothesis

To evaluate the clinical efficacy and safety of efficacy and safety study comparing the fixed combination of two antihypertensive agents, indapamide and amlodipine in a single-pill versus free dual monocomponents in patients having with mild to moderate uncontrolled essential hypertension.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

International multicentre randomised open-label - 12-weeks 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 below to request a patient information sheet

Condition

Essential hypertension

Intervention

Single-pill combination of Indapamide SR 1.5mg/ Amlodipine 5mg versus free dual therapy. At Week 6, the patient can be uptitrated to Indapamide SR 1.5mg/ Amlodipine 10mg versus free dual therapy. The total treatment duration is 12 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Indapamide and amlodipine

Primary outcome measures

Decrease of Office systolic blood pressure (SBP) (supine SBP value in mmHg, after 12 weeks)

Secondary outcome measures

1. SBP, diastolic blood pressure (DBP) and derivate parameters decrease after 12 weeks
2. Response to treatment and normalization of BP after 12 weeks
3. Home Blood Pressure Monitoring (HBPM) parameters efficacy after 12 weeks (HBPM device)
4. Safety of investigational drug products

Overall trial start date

24/05/2014

Overall trial end date

31/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

­1. Men or women of any ethnic origin, 18 years or older
­2. Mild to moderate essential combined systolic and diastolic hypertension or isolated systolic 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. Orthostatic hypotension
3. Hypertension known to be resistant to diuretics and calcium channel inhibitors (given separately or in combination)
4. Secondary hypertension
5. Complicated hypertension
6. Diabetes mellitus type I and type II under treatment
7. Any history or known severe disease likely to interfere with the conduct of the study

Recruitment start date

24/05/2014

Recruitment end date

31/01/2015

Locations

Countries of recruitment

Armenia, Russian Federation

Trial participating centre

State Institution of Higher Professional Education “Volgograd State Medical University of Ministry of Health and Social Development of Russian Federation”
Volgograd
400000
Russian Federation

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/CL3-05520-005_synopsis_report.pdf

Publication summary

Publication citations

Additional files

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. 04/12/2017: results summary added.