A clinical study to test the safety and the efficacy of a single-pill combination of 2 antihypertensive and 1 lipid-lowering drug in patients already well treated with the concomitant administration of the same three drugs on separate tablets

ISRCTN	ISRCTN27159806
DOI	https://doi.org/10.1186/ISRCTN27159806
Protocol serial number	CL3-05153-008
Sponsor	Institut de Recherche Internationales Servier
Funder	ADIR

Submission date: 06/12/2017
Registration date: 02/02/2018
Last edited: 16/11/2018

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

Dr Hoang Hai Nguyen
Scientific

01 No Trang Long, Binh Thanh Dist
Ho Chi Minh
70000
Viet Nam

Study information

Primary study design	Interventional
Study design	Open-label randomized prospective local multicenter study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An open label study to assess the safety and efficacy of Atorvastatin/Amlodipine/Perindopril fixed-dose combination in adult patients, following four weeks of adequate treatment with atorvastatin, amlodipine and perindopril given concurrently
Study objectives	To assess the safety and efficacy of Atorvastatin/Amlodipine/Perindopril fixed-dose combination in adult patients.
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	Hypertension and dyslipidemia
Intervention	A total of 130 patients were included and randomized in a 1:1 ratio to one of the 2 free combination treatment dosage for 4 weeks: 1. Atorvastatin 10 mg, Amlodipine 5 mg and Perindopril 5 mg 2. Atorvastatin 20 mg, Amlodipine 5 mg and Perindopril 5 mg At Visit 2 (Week 4): Patients with blood pressure control were switched from their current free combination to the fixed-dose combination at the same dose levels. Patients with uncontrolled BP were up-titrated to: Atorvastatin/Amlodipine/Perindopril FDC 20/5/10 mg At Visit 3 (Week 8), any patient who is using either Atorvastatin/Amlodipine/Perindopril FDC 20/5/5 mg or 10/5/5 mg and having 140 mmHg ≤ SBP < 160 mmHg or 90 mmHg ≤ DBP < 100 mmHg, will also be up-titrated to Atorvastatin/Amlodipine/Perindopril 20/5/10 mg.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Atorvastatin, amlodipine, perindopril
Primary outcome measure(s)	Safety: the number and percentage of patients reporting at least one adverse event during the usage of either Fixed Dose Combination 10/5/5 or 20/5/5; or 20/5/10 mg W4 to W12 Efficacy: the percentage of patients who, after 8 weeks of the FDC treatment with 10/5/5 or 20/5/5 strengths, maintained the BP (office-based measurement) <140/90 mmHg and were previously treated with the free combination of atorvastatin, amlodipine, and perindopril, given concurrently at the same dose level as in the combination and controlled on the blood pressure after 4 weeks of treatment with the free combination W4 to W12 By automatic device at office
Key secondary outcome measure(s)	1. Safety: the number and percentage of patients reporting at least one adverse event during the usage of either free combination 10+5+5 or 20+5+5 mg 2. Inclusion to W4/premature withdrawal 3. Efficacy: 3.1. Change in SBP and DBP from baseline (Week 0) to Week 12 for patients having same dosage of Atorvastatin, Amlodipine and Perindopril 3.2. Percentage and absolute change in LDL-C from baseline (Week 0) to Week 12 for patients having same dosage of Atorvastatin, Amlodipine and Perindopril, and percentage of patients maintaining or achieving LDL-c target (<100 mg/dL) (all groups) 3.3. The percentage of patients who, after 4 or 8 weeks of FDC treatment with 20/5/10 mg strength, achieved the BP (office-based measurement) <140/90 mmHg
Completion date	13/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	130
Key inclusion criteria	1. Confirmed inadequate BP control before study drug dispensing: for combined systolic and diastolic hypertension 2. Confirmed LDL-C value by the laboratory test performed at Selection visit 3. Patients who provide written informed consent to participate in the study 4. Outpatients of 18 years of age or above (male and female)
Key exclusion criteria	1. Known symptomatic orthostatic hypotension 2. Malignant hypertension 3. Secondary hypertension 4. Isolated diastolic hypertension 5. History of hypertension 6. Known diabetes mellitus type I or type II 7. History or current presence of lymphedema or leg edema (unilateral or bilateral) of venous origin 8. Presence of severe rhythm or conduction disorder 9. Any history of heart failure, New York Heart Association (NYHA) classification III or IV 10. Patients with contra-indications to statins, especially to Atorvastatin 11. Patients with contra-indications to calcium channel inhibitors, especially to Amlodipine 12. Patients with contra-indications to ACE inhibitors, especially to Perindopril arginine: 13. History of myopathy, familial history of hereditary muscular disorders
Date of first enrolment	19/04/2016
Date of final enrolment	14/09/2016

Locations

Countries of recruitment

Viet Nam

Study participating centres

Gia Dinh People’s Hospital

700000
Viet Nam

Thong Nhat Hospital

700000
Viet Nam

Tam Duc Heart Hospital

700000
Viet Nam

Bach Mai Hospital

100000
Viet Nam

National Geriatrics Hospital

100000
Viet Nam

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/ after the Marketing Authorisation has been granted.

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

16/11/2018: Publication citation added.
03/07/2018: Link to basic results added.