check_circleStudy Completed

Hypertension

Bayer Identifier:
13176
ClinicalTrials.gov Identifier:
NCT01287260
EudraCT Number:
Not Available
EU CT Number:
Not Available
High Dose BAYA1040_Nifedipine: a dose-comparative study

Trial purpose

This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - 20 years or older
    - Japanese male or female
    - Outpatient with essential hypertension
    - Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug

  • - Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more
    - Patients with secondary hypertension or hypertensive emergency

Trial summary

Enrollment Goal
352
Trial Dates
January 2011 - August 2011
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
Completed
Shizuoka Tokushukai HospitalShizuoka, 421-0193, Japan
Completed
Yao Tokushukai General HospitalYao, 581-0011, Japan

Primary Outcome

  • Efficacy changes measured by sitting diastolic blood pressure (DBP)
    date_rangeTime Frame:
    Up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Efficacy changes measured by sitting systolic blood pressure (SBP)
    date_rangeTime Frame:
    Up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
    date_rangeTime Frame:
    Up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
    date_rangeTime Frame:
    Up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

A multicenter, double-blind, parallel-group comparative study between oral BAYA1040_CR 80 mg and 40 mg for 8 weeks in patients with essential hypertension for whom oral BAYA1040_CR 40 mg is insufficient
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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