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

• Register: ISRCTN
• Last refreshed on: 10 December 2018
• Main ID: ISRCTN27159806
• Date of registration: 02/02/2018
• Prospective Registration: No
• Primary sponsor: Institut de Recherche Internationales Servier
• Public title: 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
• 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
• Date of first enrolment: 19/04/2016
• Target sample size: 130
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN27159806
• Study type: Interventional
• Study design: Open-label randomized prospective local multicenter study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Viet Nam

Contacts

• Name: Hoang Hai Nguyen

Key inclusion & exclusion criteria

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)

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension and dyslipidemia
Circulatory System

Intervention(s)

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.

Primary Outcome(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

Secondary Outcome(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

Secondary ID(s)

CL3-05153-008

Source(s) of Monetary Support

ADIR

Ethics review

Status:
Approval date:
Contact:

Ethics approval was obtained before recruitment of the first participants

Results

• Results available: Yes
• Date Completed: 13/12/2016