Amlodipine Prevents Morning Blood Pressure Surge Study (ARMORS)

This study has been completed.
Sponsor:
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: May 21, 2014
Last verified: May 2014
  Purpose
  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.

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 ]

Enrollment: 510
Study Start Date: October 2009
Study Completion Date: March 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Jiao Tong 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: May 21, 2014
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
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Nifedipine
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Tocolytic Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014