High Dose BAYA1040_Nifedipine: a Long Term Combination Study

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Nifedipine (Adalat, BAYA1040)

• Registration Number: NCT01294215
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Primary Completion: 2011-11
• Study Completion: 2012-06
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Nifedipine (Adalat, BAYA1040)	-

Primary Outcome Measures

Name	Time	Method
Efficacy changes measured by sitting diastolic blood pressure (DBP)	Up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy changes measured by sitting systolic blood pressure (SBP)	Up to 52 weeks
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines	Up to 52 weeks
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP	Up to 52 weeks
Safety variables	Up to 30 days after the last dose of study drug	Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.