The Pharmacokinetics of Nifedipine Controlled Release Tablets in Hypertensive Patients on Hemodialysis

• Status: Unknown status
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, open, non-randomized, non-controlled study. 20 patients with hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients had mild to moderate hypertension and are receiving antihypertensive agents.

This study was designed to investigate effects of Adalat GITS on hemodialytic blood pressures in patients with chronic hemodialysis by using ABPM and measuring the drug plasma concentrations. For the purpose of investigating the influence of hemodialysis on the drug plasma concentration as well as its efficacy, it should be necessary to assign the subjects with the Adalat monotherapy. Since most patients in the hemodialysis center will be those who need and already receive combination therapy, it would be practical to start Adalat 60mg/day monotherapy to remain similar antihypertensive effect when discontinuing the previous treatment in this study population to be screened and enrolled. And taking into the consideration of clinical practice, few patients undergoing hemodialysis could be well controlled by low dose Adalat 30mg/day alone. So this study will evaluate the effect and safety of Adalat GITS 60mg/day alone and thereafter the influence of hemodialysis on the drug plasma concentration without any other possible drug interaction. The agents are given orally once a day at 08:00h and patients are followed for at least 4 weeks. After that,the patients whose blood pressure are well controlled by Adalat GITS 60mg/day by office blood pressure would be enrolled for further ABPM assessment and plasma concentration evaluation.

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

Details

• Lead Sponsor: Guangzhou First Municipal People’s Hospital; Guangzhou First People's Hospital
• Treatments: Nifedipine

Criteria

Inclusion Criteria:

1. Males or females >= 18 years

2. The patients are on chronic maintenance hemodialysis and dialyzed three times a week for 240 minutes.

3. The patients have mild to moderate hypertension and are receiving antihypertensive agents.

4. The dry weight of all patients is stable for at least 3 months. Dry weight is defined as the end-dialysis weight that was regularly reached without signs of dehydration or overhydration.

5. Patients who have given a written informed consent.

6. Females who are not yet in menopause should have an accepted contraception. A urine pregnancy test should be done if applicable, too.

Exclusion Criteria:

1. Patients with an interdialytic increase of greater than 5% of body weight are excluded.

2. Known hypersensitivity to nifedipine or any of the ingredients

3. Moderate to severe hepatic insufficiency (ALT/AST>2 x ULN (= Upper Limit of Normal))

4. Cardiovascular disease such as atrial fibrillation, congestive heart failure, valvular or ischemic heart disease, or stroke, or life-threatening arrhythmia

5. fluid effusion

6. inflammatory disease

7. malignancies

8. Female patients who are pregnant or lactating.

9. Other contraindications in package insert.