Condition category
Circulatory System
Date applied
06/12/2017
Date assigned
02/02/2018
Last edited
03/07/2018
Prospective/Retrospective
Retrospectively 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

Dr Hoang Hai Nguyen

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-05153-008

Study information

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

Acronym

Study hypothesis

To assess the safety and efficacy of Atorvastatin/Amlodipine/Perindopril fixed-dose combination in adult patients.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Open-label randomized prospective local multicenter 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

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 names

Atorvastatin, amlodipine, perindopril

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

17/07/2015

Overall trial end date

13/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130 patients randomized

Participant 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

Recruitment start date

19/04/2016

Recruitment end date

14/09/2016

Locations

Countries of recruitment

Viet Nam

Trial participating centre

Gia Dinh People’s Hospital
700000
Viet Nam

Trial participating centre

Thong Nhat Hospital
700000
Viet Nam

Trial participating centre

Tam Duc Heart Hospital
700000
Viet Nam

Trial participating centre

Bach Mai Hospital
100000
Viet Nam

Trial participating centre

National Geriatrics Hospital
100000
Viet Nam

Sponsor information

Organisation

Institut de Recherche Internationales Servier

Sponsor details

50
rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

ADIR

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. 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/ after the Marketing Authorisation has been granted.

Intention to publish date

13/06/2018

Participant level data

Available on request

Basic results (scientific)

https://clinicaltrials.servier.com/wp-content/uploads/CL3-05153-008_synopsis_report.pdf

Publication list

Publication citations

Additional files

Editorial Notes

03/07/2018: Link to basic results added.