Amlodipine Prevents Morning Blood Pressure Surge Study

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

1. Study name:Amlodipine Prevents Morning Blood Pressure Surge Study

2. Study drugs:amlodipine (Norvasc®) and nifedipine GITS (Adalat®)

3. Rationale: Several recent studies compared 24-h blood pressure lowering effect of these 2 dihydropyridine drugs, amlodipine and nifedipine GITS, but produced inconsistent results. Therefore, a randomized controlled trial with a larger sample size is required to compare these 2 dihydropyridines in the blood pressure control over 24 hours in general and during early morning hours and at night in particular.

4. Objective: The primary objective of this study is to test the hypothesis that amlodipine compared with nifedipine GITS has a stronger effect in preventing morning blood pressure surge (4 am to 8 am) in mild to moderate hypertensive patients.The secondary objective of the study is to compare the effects of amlodipine and nifedipine GITS in reducing nighttime blood pressure (10 pm to 4 am) in patients with a decreased nocturnal blood pressure fall.

5. Study design: The present study is designed as a randomized, actively controlled, multi-centre parallel group trial (phase Ⅳ) with two equally sized treatment groups: amlodipine and nifedipine GITS.

6. Study population: 500 hypertensive patients meet the inclusion/exclusion criteria.

7. Randomization and treatment: After stratification for centre, 500 eligible patients will be randomized into 2 groups. 250 will receive amlodipine 5 mg per day, and 250 will receive nifedipine GITS 30 mg per day. At 4 weeks of follow-up, the drug dosage per day may increase to 10 mg of amlodipine and 60 mg of nifedipine GITS, if blood pressure measured in doctor's office cannot be controlled to a level below 140/90 mm Hg. If there were no compelling indication, no other antihypertensive drug is allowed during the 2-month trial.

8. Follow up: All patients should give written informed consent at entry into the present study. In addition to 24-h ambulatory blood pressure monitoring, patients should also undergo a questionnaire survey and clinical measurements including clinic blood pressure. Patients will be followed up at the end of 4 weeks and 8 weeks after randomization.

9. Sample size estimation: The number of required subject for the whole trial is 500.

10. Timeline: October 2009 to July 2013.

11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

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

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Amlodipine; Nifedipine

Criteria

Inclusion Criteria:

• Age: 40 to 70 years old.

• Untreated patients or those on monotherapy of antihypertensive drugs but with uncontrolled blood pressure in the ranges of 140-160/90-100 mmHg.

• Patients on antihypertensive medication should discontinue their antihypertensive treatment for at least 4 weeks. During the 4 weeks run-in period, all patients should have 2 clinic visits. At each visit, blood pressure will be measured 3 times consecutively. The average of these 6 readings from 2 clinic visits should be in the range of 140-180 systolic or 90-110 diastolic mm Hg. 24-h mean blood pressure should be equal to or higher than 130 mm Hg systolic and 80 mm Hg diastolic.

• The patients should sign the consent form prior to the participation in the trial, adhere to the study design, and can visit the outpatient clinic on his/her own.

Exclusion Criteria:

• With life-threatening disease.

• With myocardial infarction or stroke in the last 2 years.

• With contraindications to a dihydropyridine calcium channel blocker.

• Current participation in another trial or trials.