Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient

Pfizer

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00443456

A0531086

Details and patient eligibility

About

To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).

Full description

NCT00415623 (protocol A0531085)

Enrollment: 134 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety
• Patients who had a treatment compliance rate of at least 80%

Exclusion criteria

• The patient who met the discontinuation criteria in the preceding study A0531085

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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134 participants in 1 patient group

Single

Experimental group

Treatment:

Drug: Amlodipine