Amlodipine Prevents Morning Blood Pressure Surge Study (ARMORS)
|ClinicalTrials.gov Identifier: NCT01030081|
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : May 22, 2014
- Study name:Amlodipine Prevents Morning Blood Pressure Surge Study
- Study drugs:amlodipine (Norvasc®) and nifedipine GITS (Adalat®)
- 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.
- 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.
- 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.
- Study population: 500 hypertensive patients meet the inclusion/exclusion criteria.
- 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.
- 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.
- Sample size estimation: The number of required subject for the whole trial is 500.
- Timeline: October 2009 to July 2013.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Amlodipine (Norvasc®) Drug: Nifedipine GITS (Adalat® XL 30||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||510 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Phase Ⅳ Trial With Two Equally Sized Treatment Groups: Amlodipine And Nifedipine GITS|
|Study Start Date :||October 2009|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
|Experimental: Amlodipine (Norvasc®)||
Drug: Amlodipine (Norvasc®)
Amlodipine (Norvasc®), tablet, 5 mg
|Active Comparator: Nifedipine GITS (Adalat® XL 30)||
Drug: Nifedipine GITS (Adalat® XL 30
Nifedipine GITS (Adalat® XL 30), controlled released tablet, 30 mg
- the change from baseline in the mean systolic blood pressure during the morning hours (4 am to 8 am) of the first 24-hour ambulatory blood pressure monitoring at week 8 after randomization [ Time Frame: 8 weeks ]
- the change from baseline in mean systolic blood pressure during the morning, mean systolic blood pressure at night, mean systolic blood pressure during the morning after missed dose, mean 24 h systolic blood pressure and mean daytime blood pressure [ Time Frame: 4, 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030081
|Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine|
|Shanghai, China, 200025|
|Principal Investigator:||Jiguang Wang, MD, PhD||Shanghai Jiao Tong University School of Medicine|