Amlodipine Prevents Morning Blood Pressure Surge Study (ARMORS)
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|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|
|Actual Primary Completion Date :||March 2013|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|