High Dose BAYA1040 CR: a Long Term Extension Study

Hypertension Clinical Trial

Official title:

A Multicenter, Open Label, Long Term Extension Study of Oral BAYA1040 CR 80 mg (40 mg Bid) for 44 Weeks in Patients With Essential Hypertension (Extension From Study 13176)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355367
• Other study ID #: 14023
• Status: Completed
• Phase: Phase 3
• First received: April 21, 2011
• Last updated: January 28, 2014
• Start date: January 2011
• Est. completion date: April 2012

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 safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable

Exclusion Criteria:

• Patients with expected difficulties for the continuous 1 year follow up

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Nifedipine (Adalat, BAYA1040)
BAYA1040 CR 40mg BID

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	Safety variables will be summarized using descriptive statistics based on adverse events collection		Week 52	Yes
Secondary	Changes from baseline in diastolic blood pressure (DBP) while sitting		Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52	No
Secondary	Changes from baseline in systolic blood pressure (SBP) while sitting		Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52	No
Secondary	Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines		Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52	No
Secondary	Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP		Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52	No

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