NCT01355367

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Jan 2011

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
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

April 21, 2011

Last Update Submit

January 28, 2014

Conditions

Hypertension

Keywords

BAYA1040 CRNifedipineEssential hypertensionJapanese PatientsPhase IIIExtension study

Outcome Measures

Primary Outcomes (1)

  • Safety variables will be summarized using descriptive statistics based on adverse events collection

    Week 52

Secondary Outcomes (4)

  • Changes from baseline in diastolic blood pressure (DBP) while sitting

    Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52

  • Changes from baseline in systolic blood pressure (SBP) while sitting

    Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52

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

    Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52

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

    Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Nifedipine (Adalat, BAYA1040)

Interventions

Nifedipine (Adalat, BAYA1040)DRUG

BAYA1040 CR 40mg BID

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable

You may not qualify if:

  • Patients with expected difficulties for the continuous 1 year follow up

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

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

May 18, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

April 1, 2012

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

JP(22)