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High Dose BAYA1040 CR: a Long Term Extension 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 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.

Clinical Details

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)

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

Primary outcome: Safety variables will be summarized using descriptive statistics based on adverse events collection

Secondary outcome:

Changes from baseline in diastolic blood pressure (DBP) while sitting

Changes from baseline in systolic blood pressure (SBP) while sitting

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

Eligibility

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

Criteria:

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

Locations and Contacts

Shizuoka 421-0193, Japan

Hirosaki, Aomori 036-8082, Japan

Kamagaya, Chiba 273-0100, Japan

Asahikawa, Hokkaido 070-0061, Japan

Asahikawa, Hokkaido 078-8214, Japan

Sapporo, Hokkaido 063-0841, Japan

Sapporo, Hokkaido 003-0825, Japan

Sapporo, Hokkaido 004-0004, Japan

Sapporo, Hokkaido 007-0841, Japan

Sapporo, Hokkaido 062-0053, Japan

Sapporo, Hokkaido 003-0026, Japan

Sapporo, Hokkaido 064-0803, Japan

Sapporo, Hokkaido 064-0807, Japan

Kawasaki, Kanagawa 210-0852, Japan

Daito, Osaka 574-0074, Japan

Kishiwada, Osaka 596-8522, Japan

Yao, Osaka 581-0011, Japan

Tokorozawa, Saitama 359-1141, Japan

Hachioji, Tokyo 192-0046, Japan

Meguro, Tokyo 152-0031, Japan

Minato, Tokyo 105-7390, Japan

Minato, Tokyo 108-0075, Japan

Additional Information

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Starting date: January 2011
Last updated: January 28, 2014

Page last updated: August 23, 2015

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