High Dose BAYA1040_Nifedipine: a Dose-comparative Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Nifedipine (Adalat, BAYA1040)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01287260

13176

Details and patient eligibility

About

This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.

Enrollment: 352 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 whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug

Exclusion criteria

• Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more
• Patients with secondary hypertension or hypertensive emergency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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352 participants in 2 patient groups

Arm1

Experimental group

Treatment:

Drug: Nifedipine (Adalat, BAYA1040)

Drug: Nifedipine (Adalat, BAYA1040)

Arm 2

Active Comparator group

Treatment:

Drug: Nifedipine (Adalat, BAYA1040)

Drug: Nifedipine (Adalat, BAYA1040)