A Multicenter, Double-blind, Parallel-group Comparative Study Between Oral BAYA1040_CR 80 mg and 40 mg for 8 Weeks in Patients With Essential Hypertension for Whom Oral BAYA1040_CR 40 mg is Insufficient

Bayer0 sites352 target enrollmentJanuary 2011

ConditionsHypertension

InterventionsNifedipine (Adalat, BAYA1040)

DrugsNifedipine (Adalat, BAYA1040)

Overview

Phase: Phase 3
Intervention: Nifedipine (Adalat, BAYA1040)
Conditions: Hypertension
Sponsor: Bayer
Enrollment: 352
Primary Endpoint: Efficacy changes measured by sitting diastolic blood pressure (DBP)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

August 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Arm1

Intervention: Nifedipine (Adalat, BAYA1040)

Arm 2

Intervention: Nifedipine (Adalat, BAYA1040)

Outcomes

Primary Outcomes

Efficacy changes measured by sitting diastolic blood pressure (DBP)

Time Frame: Up to 8 weeks

Secondary Outcomes

Efficacy changes measured by sitting systolic blood pressure (SBP)(Up to 8 weeks)
Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines(Up to 8 weeks)
Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP(Up to 8 weeks)