High Dose BAYA1040_Nifedipine: a Long Term Combination Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Nifedipine (Adalat, BAYA1040)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294215

14024

Details and patient eligibility

About

This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.

Enrollment: 72 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 20 years or older
• Japanese male or female
• Outpatient with essential hypertension
• Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study

Exclusion criteria

• Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
• Patients with secondary hypertension or hypertensive emergency

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Nifedipine (Adalat, BAYA1040)