A Phase II Cinical Trial of ranidipine Enteric-Coated Tablets

Efficacy and Safety of Aranidipine Enteric-Coated Tablets Compared to Amlodipine in Chinese Patients With Mild to Moderate Essential Hypertension: A Phase II, Multicenter, Randomized, Double-Blind, Pa

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001538

Enrollment

Unknown

Registered

2011-08-01

Start date

2008-06-01

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

mild to moderate essential hypertension.

Interventions

Group A:aranidipine 5 mg orally once daily for 10 weeks

Group B:amlodipine 5 mg orally once daily for 10 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female patients aged 18–75 years with mild to moderate essential hypertension defined as seated diastolic blood pressure (SeDBP) 90-109 mmHg and seated systolic blood pressure (SeSBP) < 180 mmHg were eligible for participation.

Exclusion criteria

Exclusion criteria: 1. severe hypertension (defined as a SeDBP >=110 mmHg or SeSBP >=180 mmHg), or secondary hypertension; 2. unstable angina; 3. New York Heart Association class III or IV chronic heart failure; 4. significant arrhythmia or valvular heart disease; 5. cerebrovascular accident, myocardial infarction, or a history of percutaneous coronary intervention or cardiac surgery within the previous 6 months; 6. confirmed evidence of hepatic or renal dysfunction (transaminases exceeding twice the upper limit of normal, serum creatinine exceeding 1.5 times the upper limit of normal); 7. failure controlled diabetes defined as fasting blood glucose (FBG) >11.1mmol/L; 8. gastrointestinal diseases, including ulcer or a surgery, which could interfere with drug absorption; 9. pregnant or lactant women; 10. obesity(body mass index > 30 kg/m2); 11. oncomitant use of medications known to significantly affect BP; 12. and other conditions that physicians considered inappropriate to the study.

Design outcomes

Primary

Measure	Time frame
reduction of seated diastolic blood pressure after 10-week treatment;	—

Secondary

Measure	Time frame
the reaching target blood pressure rates;the trough/peak ratios of 24h ambulatory blood pressure;	—

Countries

China

Contacts

Public ContactChaomei Fan

Peking Union Medical College and Chinese Academy of Medical Sciences, Ministry of Health, Cardiovasc

fred_fan2004@163.com+86 10 88396298

Outcome results

None listed

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