Compare the Effects of Lercanidipine Hydrochloride Tablet (Zanidip®) and Felodipine Sustained-Release Tablet for Hypertension

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be compare Felodipine sustained-release tablets, to Lercanidipine hydrochloride tablets (Zanidip®) for the treatment of patients with mild-to-moderate primary hypertension and to investigate the influence on patients' heart rate and blood pressure variability.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Treatments: Felodipine; Lercanidipine

Criteria

Inclusion Criteria:

Study population is patients with mild-to-moderate primary hypertension. The diagnosis of the patients should be in accordance with the diagnostic criteria in Chinese Guidelines for Hypertension Prevention and Treatment (2010). Patients meeting all of the following criteria are enrolled in the study:

1. Male or female patient, aged 18-75 years;

2. Mild-to-moderate primary hypertension;

3. 90mmHg ≤ DBP < 110 mmHg and SBP < 180mmHg;

4. Patient's 24h mean blood pressure (measuring by ABPM)> 130/80mmHg;

5. Patient has signed informed consent form;

Exclusion Criteria:

1. Secondary hypertension;

2. Severe hypertension or other antihypertensive drugs unable to be discontinued;

3. History of heart failure or record of LVEF < 40%, cardiomyopathy or valvular heart disease;

4. Severe arrhythmia, including arrhythmia, atrial fibrillation, atrial flutter, ventricular tachycardia, advanced atrioventricular block and sick sinus syndrome;

5. History of myocardial infarction or unstable angina during the past three months;

6. Type I diabetes;

7. Type II diabetes, fasting blood-glucose ≥ 11.1mmol/L;

8. ALT or AST ≥ 1.5 times the upper limit of the reference value;

9. Abnormal thyroid function (hyperthyroidism and hypothyroidism);

10. Acute or chronic renal insufficiency (serum creatinine of male patient > 176.8 μmol/L and female patient > 159.12μmol/L);

11. Patient suffers from anxiety or depression;

12. Mental disease or senile dementia;

13. Hypersensitivity to calcium channel blockers;

14. Pregnancy, lactation; women of child-bearing age use hormonal contraception, or perimenopause women receive hormone treatment;

15. History of drug or alcohol abuse within two years prior to enrollment;

16. Concomitant administration of the following CYP3A4 strong inhibitors: ketoconazole, itraconazole, nefazodone, triacetyloleandomycin, clarithromycin, ritonavir, nelfinavir. Or other CYP3A4 inhibitors: erythromycin, verapamil, saquinavir, fluconazole; inducers of drugmetabolizing enzymes of liver (phenytoin, carbamazepine, rifampicin and barbiturates);

17. Patient has suffered from cerebrovascular accident, severe trauma or undergone major operation;

18. BMI ≥ 30 kg/m2;

19. Participation in other clinical trials during the past three months;

20. Investigator judged the patient unsuitable to participate in this trial.