An efficacy and safety study comparing the fixed combination of two antihypertensive agents, indapamide and amlodipine in a single-pill, to the same drugs given separately, in patients with mild to moderate uncontrolled essential hypertension

ISRCTN	ISRCTN63697536
DOI	https://doi.org/10.1186/ISRCTN63697536
Protocol serial number	CL3-05520-005
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 27/03/2014
Registration date: 28/04/2014
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

Prof Sergey V. Nedogoda
Scientific

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

Study information

Primary study design	Interventional
Study design	International multicentre randomised open-label - 12-weeks study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Indapamide and amlodipine
Primary outcome measure(s)	Decrease of Office systolic blood pressure (SBP) (supine SBP value in mmHg, after 12 weeks)
Key secondary outcome measure(s)	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
Completion date	31/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key 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
Key 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
Date of first enrolment	24/05/2014
Date of final enrolment	31/01/2015

Locations

Countries of recruitment

Armenia
Russian Federation

Study 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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.