NCT01287260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

January 30, 2011

Last Update Submit

January 28, 2014

Conditions

Hypertension

Keywords

BAYA1040_NifedipineNifedipineEssential hypertensionJapanese PatientsPhase III13176

Outcome Measures

Primary Outcomes (1)

  • Efficacy changes measured by sitting diastolic blood pressure (DBP)

    Up to 8 weeks

Secondary Outcomes (3)

  • Efficacy changes measured by sitting systolic blood pressure (SBP)

    Up to 8 weeks

  • Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines

    Up to 8 weeks

  • Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP

    Up to 8 weeks

Study Arms (2)

Arm1

EXPERIMENTAL
Drug: Nifedipine (Adalat, BAYA1040)

Arm 2

ACTIVE COMPARATOR
Drug: Nifedipine (Adalat, BAYA1040)

Interventions

Nifedipine (Adalat, BAYA1040)DRUG

BAYA1040\_Nifedipine 40mg twice daily (BID)

Arm1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Hirosaki, Aomori, 036-8082, Japan

Location

Unknown Facility

Kamagaya, Chiba, 273-0100, Japan

Location

Unknown Facility

Asahikawa, Hokkaido, 070-0061, Japan

Location

Unknown Facility

Asahikawa, Hokkaido, 078-8214, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 003-0026, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 003-0825, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 004-0004, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 007-0841, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 062-0053, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 063-0841, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 064-0803, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 064-0807, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 210-0852, Japan

Location

Unknown Facility

Daitō, Osaka, 574-0074, Japan

Location

Unknown Facility

Kishiwada, Osaka, 596-8522, Japan

Location

Unknown Facility

Yao, Osaka, 581-0011, Japan

Location

Unknown Facility

Tokorozawa, Saitama, 359-1141, Japan

Location

Unknown Facility

Shizuoka, Shizuoka, 421-0193, Japan

Location

Unknown Facility

Hachiōji, Tokyo, 192-0046, Japan

Location

Unknown Facility

Meguro City, Tokyo, 152-0031, Japan

Location

Unknown Facility

Minato, Tokyo, 105-7390, Japan

Location

Unknown Facility

Minato, Tokyo, 108-0075, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23945965DERIVED

MeSH Terms

Conditions

HypertensionEssential Hypertension

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2011

First Posted

February 1, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

JP(22)