Efficacy and safety of the fixed oral perindopril arginine 5 mg/ amlopidine 5 mg combination compared with perindopril tert-butylamine 4 mg alone in patients not adequately controlled with perindopril tert-butylamine 4 mg monotherapy.

Efficacy and safety of the fixed oral perindopril arginine 5 mg/ amlopidine 5 mg combination compared with perindopril tert-butylamine 4 mg alone in patients not adequately controlled with perindopril tert-butylamine 4 mg monotherapy. A randomised double blind 12 weeks study with up titration after

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12001986

Enrollment

Unknown

Registered

2012-02-24

Start date

2010-10-11

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Primary hypertension

Interventions

1:Perindopril/amlodipine combination: perindopril 5 mg /amlodipine 5 mg - titrated in patients non controlled after 8 weeks to perindopril 10 mg /amlodipine 5 mg. One Oral capsule or one oral capsule

2:Perindopril tert-butylamine 4mg - titrated in patients non controlled after 8 weeks to perindopril 5 mg /amlodipine 5 mg – One oral capsule, or one oral capsule and one oral tablet taken once daily

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Male or female, aged 18 to 75 years, mild to moderate primary hypertensive patients without complications; At selection, diastolic blood pressure 95mmHg to 110mmHg and systolic blood pressure 150mmHg to 180mmHg; After taking perindopril 4mg treatment for four weeks, subjects with blood pressure levels within the following range were eligible for inclusion: At inclusion, diastolic blood pressure 90mmHg to 110 mmHg and systolic blood pressure 140mmHg to 180mmHg.

Exclusion criteria

Exclusion criteria: Women who were pregnant or women of childbearing age who were not taking a medically accepted contraceptive; Patients with known history of cerebrovascular stroke or other cerebrovascular disease, unstable angina pectoris, myocardial infarction, coronary revascularization, chronic heart failure, uncontrolled cardiac arrhythmia (such as atrial fibrillation or atrial flutter), level II or III atrioventricular heart-block, type I diabetes or uncontrolled type 2 diabetes, insufficient renal function, insufficient liver function, symptomatic orthostatic hypotension, history of alcohol or drug abuse or any other drug are contraindicated and are excluded.

Design outcomes

Primary

Measure	Time frame
Sitting systolic blood pressure (change from baseline);	—

Secondary

Measure	Time frame
Sitting diastolic blood pressure;normal blood pressure, response to treatment;pulse pressure and mean blood pressure;24-hour ambulatory blood pressure monitoring parameters;safety assessment;	—

Countries

China

Contacts

Public ContactProfessor Hu Da-yi

Dayi.hu@medmail.com.cn+86 10 88324726

Outcome results

None listed

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