Status:
COMPLETED
A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Hypertension
Eligibility:
All Genders
20-79 years
Phase:
PHASE3
Brief Summary
The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg
Eligibility Criteria
Inclusion
- Untreated Hypertensive Patients: An systolic blood pressure of \>=160 mmHg or diastolic blood pressure \>=100mmHg.
- Treated Hypertensive Patients: An systolic blood pressure of \>=140 mmHg or diastolic blood pressure of \>= 90 mmHg.
- Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) \>=140 mmHg
- Patients with a screening treatment compliance rate \>= 80%
Exclusion
- Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00415623
Start Date
January 1 2007
End Date
October 1 2007
Last Update
February 11 2021
Active Locations (14)
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1
Pfizer Investigational Site
Kasuya-gun, Fujuoka, Japan
2
Pfizer Investigational Site
Chikushino-shi, Fukuoka, Japan
3
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
4
Pfizer Investigational Site
Koga, Fukuoka, Japan