High Dose BAYA1040 CR: a Long Term Extension Study

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01355367

Enrollment

120

Registered

2011-05-18

Start date

2011-01-31

Completion date

2012-04-30

Last updated

2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

BAYA1040 CR, Nifedipine, Essential hypertension, Japanese Patients, Phase III, Extension study

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.

Interventions

DRUGNifedipine (Adalat, BAYA1040)

BAYA1040 CR 40mg BID

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety variables will be summarized using descriptive statistics based on adverse events collection	Week 52

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026