High Dose BAYA1040 CR: a Long Term Extension Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Nifedipine (Adalat, BAYA1040)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01355367

14023

Details and patient eligibility

About

This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.

Enrollment: 120 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable

Exclusion criteria

• Patients with expected difficulties for the continuous 1 year follow up

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Nifedipine (Adalat, BAYA1040)