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Amlodipine Prevents Morning Blood Pressure Surge Study

NCT01030081 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2014-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Amlodipine (Norvasc®)

Amlodipine (Norvasc®), tablet, 5 mg

DRUG

Nifedipine GITS (Adalat® XL 30

Nifedipine GITS (Adalat® XL 30), controlled released tablet, 30 mg

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jiguang Wang, MD, PhD · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01030081 on ClinicalTrials.gov