Amlodipine Prevents Morning Blood Pressure Surge Study (ARMORS)
This study is ongoing, but not recruiting participants.
Sponsor:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01030081
First received: December 10, 2009
Last updated: January 6, 2013
Last verified: January 2013
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Purpose
- 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 | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Amlodipine (Norvasc®) Drug: Nifedipine GITS (Adalat® XL 30 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized Controlled Phase Ⅳ Trial With Two Equally Sized Treatment Groups: Amlodipine And Nifedipine GITS |
Resource links provided by NLM:
Further study details as provided by Shanghai Jiao Tong University School of Medicine:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030081
Locations
| China | |
| Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine | |
| Shanghai, China, 200025 | |
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
| Principal Investigator: | Jiguang Wang, MD, PhD | Shanghai JiaoTong University School of Medicine |
More Information
No publications provided
| Responsible Party: | Ji-Guang Wang, Director, Shanghai Jiao Tong University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01030081 History of Changes |
| Other Study ID Numbers: | ARMORS |
| Study First Received: | December 10, 2009 |
| Last Updated: | January 6, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Shanghai Jiao Tong University School of Medicine:
|
24 hour blood pressure morning blood pressure surge amlodipine nifedipine GITS |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Nifedipine Amlodipine Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Vasodilator Agents Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 23, 2013