Status:
UNKNOWN
A Study of Nifecardia SRFC and Adalat OROS in the Treatment of Patients With Essential Hypertension
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Objective: * To evaluate the antihypertensive efficacy of two brands of nifedipine 30mg in patients with hypertension. * To assess the safety of 8 weeks of therapy with two brands of nifedipine 30mg ...
Detailed Description
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, tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00173667
Last Update
December 21 2005
Active Locations (1)
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1
Cardiovascular Division, Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan