Efficacy and safety of the fixed oral perindopril arginine 5mg/amlodipine 5mg combination compared with amlodipine 5mg alone in patients not adequately controlled with amlodipine 5mg monotherapy

Efficacy and safety of the fixed oral perindopril arginine 5mg/amlodipine 5mg combination compared with amlodipine 5mg alone in patients not adequately controlled with amlodipine 5mg monotherapy. A randomised double blind 12 weeks study with up titration after 8 weeks in non controlled patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12001955

Enrollment

Unknown

Registered

2012-02-15

Start date

2010-09-30

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

Group 1 Double-blind period with perindopril argin:Perindopril/amlodipine combination: perindopril 5 mg /amlodipine 5 mg –titrated in patients non controlled after 8 weeks to perindopril 5 mg /amlodip

Group 2 Double-blind period with amlodipine:Amlodipine 5 mg –titrated in patients non controlled after 8 weeks to perindopril 5 mg / amlodipine 5mg – One oral capsule taken once daily before the morni

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Male or female, to be aged 18 to 75 years, mild to moderate primary hypertensive patients without complications. At selection, diastolic blood pressure between 95mmHg to 110mmHg and systolic blood pressure between 150 mmHg to 180mmHg. After taking amlodipine 5 mg treatment for four weeks, subjects with blood pressure levels within the following range were eligible for inclusion: At inclusion, diastolic blood pressure from 90 mmHg to 110 mmHg and systolic blood pressure between 140 mmHg 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 basel;	—

Secondary

Measure	Time frame
Sitting diastolic blood pressure;rate of normalization of blood pressure;response to treatment;pulse pressure and mean blood pressure;24-hour ambulatory blood pressure monitoring parameters;sefety 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