Clinical trial NCT01355367: High Dose BAYA1040 CR: a Long Term Extension Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: BAYA1040 CR
Nifedipine
Essential hypertension
Japanese Patients
Phase III
Extension study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: Week 52
Secondary outcomes:
measure: Changes from baseline in diastolic blood pressure (DBP) while sitting
timeFrame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Changes from baseline in systolic blood pressure (SBP) while sitting
timeFrame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
timeFrame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
timeFrame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Other outcomes:
Locations:
city: Hirosaki
country: Japan
state: Aomori
city: Kamagaya
country: Japan
state: Chiba
city: Asahikawa
country: Japan
state: Hokkaido
city: Asahikawa
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kawasaki
country: Japan
state: Kanagawa
city: Daito
country: Japan
state: Osaka
city: Kishiwada
country: Japan
state: Osaka
city: Yao
country: Japan
state: Osaka
city: Tokorozawa
country: Japan
state: Saitama
city: Hachioji
country: Japan
state: Tokyo
city: Meguro
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Shizuoka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: