check_circleStudy Completed

Hypertension

Bayer Identifier:

14023

ClinicalTrials.gov Identifier:

NCT01355367

EudraCT Number:

Not Available

EU CT Number:

Not Available
High Dose BAYA1040 CR: a long term extension study

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable
  • - Patients with expected difficulties for the continuous 1 year follow up

Trial summary

Enrollment Goal
120
Trial Dates
January 2011 - April 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
Adalat CC (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kihara Cardiovascular and Internal HospitalAsahikawa, 078-8214, Japan
Completed
Kunimoto HospitalAsahikawa, 070-0061, Japan
Completed
Shinsapporo Seiryo HospitalSapporo, 004-0004, Japan
Completed
Maruyama Rira ClinicSapporo, 064-0803, Japan
Completed
Close To You EST ClinicHirosaki, 036-8082, Japan
Completed
Shinagawa East One Medical ClinicMinato, 108-0075, Japan
Completed
Pedi-Shiodome ClinicMinato, 105-7390, Japan
Completed
Nishimura Internal Cardiovascular ClinicMeguro, 152-0031, Japan
Completed
NS ClinicHachioji, 192-0046, Japan
Completed
Koukan ClinicKawasaki, 210-0852, Japan
Completed
Nozaki Tokushukai HospitalDaito, 574-0074, Japan
Completed
Kishiwada Tokushukai HospitalKishiwada, 596-8522, Japan
Terminated
Saino ClinicTokorozawa, 359-1141, Japan
Completed
Riverside ClinicSapporo, 064-0807, Japan
Completed
Toei Hospitalsapporo, 007-0841, Japan
Completed
Yoshida Memorial HospitalSapporo, 003-0026, Japan
Completed
Sapporo Century HospitalSapporo, 003-0825, Japan
Completed
Kitano-dori Internal medicine and Cardiovascular medicine CLSapporo, 062-0053, Japan
Completed
Kotoni Medical Support ClinicSapporo, 063-0841, Japan
Completed
Kamagaya General HospitalKamagaya, 273-0100, Japan
Terminated
Shizuoka Tokushukai HospitalShizuoka, 421-0193, Japan
Terminated
Yao Tokushukai General HospitalYao, 581-0011, Japan

Primary Outcome

  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    Week 52
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Changes from baseline in diastolic blood pressure (DBP) while sitting
    date_rangeTime Frame:
    Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
    enhanced_encryption
    Safety Issue:
    No
  • Changes from baseline in systolic blood pressure (SBP) while sitting
    date_rangeTime Frame:
    Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
    date_rangeTime Frame:
    Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
    date_rangeTime Frame:
    Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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