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

Viatris

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00415623

A0531085

Details and patient eligibility

About

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

Enrollment: 305 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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305 participants in 2 patient groups

Amlodipine 5mg

Active Comparator group

Treatment:

Drug: Amlodipine

Drug: Amlodipine

Amlodipine 10mg

Experimental group

Treatment:

Drug: Amlodipine

Drug: Amlodipine