A Study of Nifecardia SRFC and Adalat OROS in the Treatment of Patients With Essential Hypertension

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Sep 12, 2005

Keywords

ClinConnect Summary

1. Introduction:

Nifedipine is one of the first calcium-channel blockers that are widely used in the treatment of hypertension. Because of its long-term application experience and safety profile, traditional nifedipine has been remodeled as a sustained released formulary of Nifecardia SRFC. Nifecardia SRFC is a new formulary designed of zero-order kinetic release system that maintain a constant plasma concentration of nifedipine and achieve the target of once daily application. Nifecardia SRFC is bioequivalence in efficacy with that of Adalat OROS which is also a sustained released type of...

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Eligibility criteria

• Inclusion Criteria:
• • Male or non-pregnant female patients aged 18-70 years.
• • Patients had hypertension with sitting systolic blood pressure 140-180 mmHg, or diastolic blood pressure 90-110 mmHg.
• • Patients must give written informed consent to participate in this study.
• Exclusion Criteria:
• • Women who are pregnant or nursing.
• • Patients have the evidence of secondary or malignant hypertension, history of severe heart disease, cerebrovascular accident within one year, or myocardial infarction within six months.
• • Patients receiving more than one anti-hypertensive agents or one antihypertensive agent with maximal recommended dosage before entrance into the trial.
• • Patients with uncontrolled diabetes mellitus.
• • Patients had known hypersensitivity or contraindication to nifedipine, other calcium channel blockers or other beta-adrenergic antagonists.
• • Patients have the evidences of hepatic dysfunction (AST, ALT\> 3 times upper limit of normal value), renal dysfunction (serum creatinine concentration\>1.5 mg/dl), pulmonary dysfunction, mental disorders or other concurrent severe disease.
• • As to the study of flow-mediated dilatation and oxidative stress, patients with diabetes mellitus, dyslipidemia, body mass index \>27, and smokers will be excluded.