Amlodipine Prevents Morning Blood Pressure Surge Study

NCT01030081 | Completed Phase 4 DMC

• 1 other identifier: ARMORS
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study name:Amlodipine Prevents Morning Blood Pressure Surge Study
2. 2.Study drugs:amlodipine (Norvasc®) and nifedipine GITS (Adalat®)
3. 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. 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. 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. 6.Study population: 500 hypertensive patients meet the inclusion/exclusion criteria.
7. 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. 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. 9.Sample size estimation: The number of required subject for the whole trial is 500.
10. 10.Timeline: October 2009 to July 2013.
11. 11.Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Conditions

Hypertension

Keywords

24 hour blood pressure; morning blood pressure surge; amlodipine; nifedipine GITS

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (1)

• 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

  4, 8 weeks

Study Arms (2)

Amlodipine (Norvasc®)

EXPERIMENTAL

Drug: Amlodipine (Norvasc®)

Nifedipine GITS (Adalat® XL 30)

ACTIVE COMPARATOR

Drug: Nifedipine GITS (Adalat® XL 30

Interventions

Amlodipine (Norvasc®) DRUG

Amlodipine (Norvasc®), tablet, 5 mg

Amlodipine (Norvasc®)

Nifedipine GITS (Adalat® XL 30 DRUG

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

Nifedipine GITS (Adalat® XL 30)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jiguang Wang, MD, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

CN (1)