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NCT01294215 Clinical Trial

High Dose BAYA1040_Nifedipine: a Long Term Combination Study

Hypertension Clinical Trial

Official title:
A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01294215
Other study ID # 14024
Secondary ID
Status Completed
Phase Phase 3
First received February 10, 2011
Last updated June 20, 2014
Start date February 2011
Est. completion date June 2012

Study information
Verified date June 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_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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date June 2012
Est. primary completion date November 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 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

Exclusion Criteria:

- Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more

- Patients with secondary hypertension or hypertensive emergency

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

Intervention

Drug:
• Nifedipine (Adalat, BAYA1040)
Nifedipine (Adalat, BAYA1040) 40mg twice a day (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 Efficacy changes measured by sitting diastolic blood pressure (DBP) Up to 52 weeks No
Secondary Efficacy changes measured by sitting systolic blood pressure (SBP) Up to 52 weeks No
Secondary Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines Up to 52 weeks No
Secondary 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 No
Secondary Safety variables Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated. Up to 30 days after the last dose of study drug Yes
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