Efficacy on systolic and diastolic blood pressure decrease and safety of once-a-day oral 5 mg Perindopril arginine salt (titrated to 10 mg).

Efficacy on systolic and diastolic blood pressure decrease and safety of once-a-day oral 5 mg Perindopril arginine salt (titrated to 10 mg). A 12-week, 2-arm, randomised, double-blind study versus once-a-day oral 4 mg perindopril tert-butylamine salt (titrated to 2 x 4 mg) in hypertensive patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12001961

Enrollment

Unknown

Registered

2012-02-08

Start date

2010-07-29

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

Hypertension

Interventions

Group 1 Double-blind period with perindopril argin:Perindopril arginine salt 5 mg -perindopril arginine salt 10 mg. Oral capsule taken once daily in the morning

Group 2 Double-blind period with perindopril tert-:Perindopril tert-butylamine salt 4mg – perindopril tert-butylamine salt 2 * 4mg. Oral capsule taken once daily in the morning

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients, aged between 18 and 75 years inclusive, with essential systolo-diastolic hypertension and who met the following criteria at inclusion:After placebo period DBP between 95 mmHg to 110 mmHg and SBP 150 mmHg to 180 mmHg.

Exclusion criteria

Exclusion criteria: 1. Hypertension treated with more than 1 antihypertensive drug including antihypertensive traditional Chinese medicine (fixed combinations of sub-therapeutic doses of two components with a first line indication were to be considered as a single drug therapy); 2. Perindopril resistant hypertension; 3. Secondary hypertension, malignant hypertension; 4. 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; 5. Positive pregnancy test (beta Human Chorionic Gonadotrophin [beta HCG]) for non menopausal women.

Design outcomes

Primary

Measure	Time frame
Non inferiority between two salts of perindopril on the change of sitting systolic blood pressure;	—

Secondary

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

Contacts

Public ContactProfessor Yong HUO

huoyong@263.net.cn+86 10 83575261

Outcome results

None listed

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