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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN27159806

Enrollment

130

Registered

2018-02-02

Start date

2016-04-19

Completion date

Unknown

Last updated

2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension and dyslipidemia Circulatory System

Interventions

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 Perindopri

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026