Status:
COMPLETED
Compare the Effects of Lercanidipine Hydrochloride Tablet (Zanidip®) and Felodipine Sustained-Release Tablet for Hypertension
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 inves...
Detailed Description
The study is designed as a multicenter, randomized, open-label, parallel-group and active controlled clinical study. The ratio of test group (lercanidipine group) and control group (felodipine group) ...
Eligibility Criteria
Inclusion
- 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:
- Male or female patient, aged 18-75 years;
- Mild-to-moderate primary hypertension;
- 90mmHg ≤ DBP \< 110 mmHg and SBP \< 180mmHg;
- Patient's 24h mean blood pressure (measuring by ABPM)\> 130/80mmHg;
- Patient has signed informed consent form;
Exclusion
- Secondary hypertension;
- Severe hypertension or other antihypertensive drugs unable to be discontinued;
- History of heart failure or record of LVEF \< 40%, cardiomyopathy or valvular heart disease;
- Severe arrhythmia, including arrhythmia, atrial fibrillation, atrial flutter, ventricular tachycardia, advanced atrioventricular block and sick sinus syndrome;
- History of myocardial infarction or unstable angina during the past three months;
- Type I diabetes;
- Type II diabetes, fasting blood-glucose ≥ 11.1mmol/L;
- ALT or AST ≥ 1.5 times the upper limit of the reference value;
- Abnormal thyroid function (hyperthyroidism and hypothyroidism);
- Acute or chronic renal insufficiency (serum creatinine of male patient \> 176.8 μmol/L and female patient \> 159.12μmol/L);
- Patient suffers from anxiety or depression;
- Mental disease or senile dementia;
- Hypersensitivity to calcium channel blockers;
- Pregnancy, lactation; women of child-bearing age use hormonal contraception, or perimenopause women receive hormone treatment;
- History of drug or alcohol abuse within two years prior to enrollment;
- 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);
- Patient has suffered from cerebrovascular accident, severe trauma or undergone major operation;
- BMI ≥ 30 kg/m2;
- Participation in other clinical trials during the past three months;
- Investigator judged the patient unsuitable to participate in this trial.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT01520285
Start Date
December 1 2011
End Date
August 1 2013
Last Update
October 16 2014
Active Locations (1)
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1
Shanghai First People's Hospital
Shanghai, China, 200000