High Dose BAYA1040_Nifedipine: a Dose-comparative Study

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287260
• Other study ID #: 13176
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2011
• Last updated: January 28, 2014
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: January 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Nifedipine (Adalat, BAYA1040)
BAYA1040_Nifedipine 40mg twice daily (BID)
• Nifedipine (Adalat, BAYA1040)
BAYA1040_Nifedipine 40mg once daily (OD)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy changes measured by sitting diastolic blood pressure (DBP)		Up to 8 weeks	No
Secondary	Efficacy changes measured by sitting systolic blood pressure (SBP)		Up to 8 weeks	No
Secondary	Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines		Up to 8 weeks	No
Secondary	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	No

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