Clinical trial NCT01287260: High Dose BAYA1040_Nifedipine: a Dose-comparative Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: BAYA1040_Nifedipine
Nifedipine
Essential hypertension
Japanese Patients
Phase III
13176
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-02-01
Enrollment: 352
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Efficacy changes measured by sitting diastolic blood pressure (DBP)
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Efficacy changes measured by sitting systolic blood pressure (SBP)
timeFrame: Up to 8 weeks
measure: Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
timeFrame: Up to 8 weeks
measure: Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a &gt;10 mmHg reduction of DBP
timeFrame: Up to 8 weeks
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:
citation: Shimamoto K, Hasebe N, Ito S, Kario K, Kimura K, Dohi Y, Kawano Y, Rakugi H, Horiuchi M, Imaizumi T, Ohya Y. Nifedipine controlled-release 40 mg b.i.d. in Japanese patients with essential hypertension who responded insufficiently to nifedipine controlled-release 40 mg q.d.: a phase III, randomized, double-blind and parallel-group study. Hypertens Res. 2014 Jan;37(1):69-75. doi: 10.1038/hr.2013.80. Epub 2013 Aug 15.