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

NCT00173667 | Unknown Phase 4

• 1 other identifier: 182CL1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 in patients with hypertension.
• To study flow-mediated dilatation and oxidative stress in nonsmoker with essential hypertension but without diabetes mellitus or dyslipidemia. Study Design:
• Head-to-head, randomized and parallel design.
• A total of 60 patients with a clinically confirmed diagnosis of hypertension will provide 30 available patients in each treatment group.
• The drugs and dosage will be as follows: Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once daily (Adalat OROS, Bayer) Method: After washout period, the eligible patients will randomly be allocated to receive two brands of nifedipine 30 mg once daily. Each patient will receive two times of ambulatory blood pressure measurement (ABPM) at both entrance and final stages of the study. The patients will also undergo complete clinical evaluation. Therapy dosage will be started at a dose of nifedipine 30 mg once daily. Dosage will be adjusted if systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg by office measurement after 4 weeks of treatment. Nifedipine will be increased to 60 mg once daily. The Ambulatory blood pressure measurement will be set to take reading at 1-hour intervals during the 24 hours assessment. Physical examination included the measurement of heart rate and blood pressure. The value will be read on Visit 1 and 3-12 hours after the last dose of nifedipine. Routine laboratory test includes hematology, blood chemistry and urinalysis. Hematology test and fasting blood chemistry test will be measured immediately before the start of treatment and after 8 weeks' treatment or at time of discontinuation. Thiobarbituric acid-reactive substances (TBARS) in patient plasma were measured for oxidative stress and endothelium-dependent flow-mediated vasodilation will also be evaluated. Possible concomitant medication will remain constant throughout the study. The physician will question the patients as to their compliance at each visit. If compliance dose not reach 80%, the subject will be dropped out.

Conditions

Hypertension

Interventions

Nifedipine 30 mg GITS DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Cardiovascular Division, Department of Internal Medicine, National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gen-Gae Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Last Updated: December 21, 2005

Record last verified: 2005-07

Locations

TW (1)