Overview

A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient

Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Amlodipine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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