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High Dose BAYA1040_Nifedipine: a Long Term Combination Study

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nifedipine (Adalat, BAYA1040) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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

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

Primary outcome: Efficacy changes measured by sitting diastolic blood pressure (DBP)

Secondary outcome:

Efficacy changes measured by sitting systolic blood pressure (SBP)

Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines

Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP

Safety variables

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ebina, Kanagawa 243-0401, Japan

Sagamihara, Kanagawa 252-0311, Japan

Kawaguchi, Saitama 332-0012, Japan

Shinjuku, Tokyo 169-0072, Japan

Additional Information

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Starting date: February 2011
Last updated: June 20, 2014

Page last updated: August 23, 2015

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