Trial Condition(s):

Hypertension

High Dose BAYA1040_Nifedipine: a dose-comparative study

Bayer Identifier:

13176

ClinicalTrials.gov Identifier:

NCT01287260

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal

352

Trial Dates

January2011

August2011

Phase

Could I receive a placebo?

Products

Adalat CC (Nifedipine, BAYA1040)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Kihara Cardiovascular and Internal Hospital Asahikawa, Japan, 078-8214	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kunimoto Hospital Asahikawa, Japan, 070-0061	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Shinsapporo Seiryo Hospital Sapporo, Japan, 004-0004	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Maruyama Rira Clinic Sapporo, Japan, 064-0803	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Close To You EST Clinic Hirosaki, Japan, 036-8082	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Shinagawa East One Medical Clinic Minato, Japan, 108-0075	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Pedi-Shiodome Clinic Minato, Japan, 105-7390	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Nishimura Internal Cardiovascular Clinic Meguro, Japan, 152-0031	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations NS Clinic Hachioji, Japan, 192-0046	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Koukan Clinic Kawasaki, Japan, 210-0852	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Nozaki Tokushukai Hospital Daito, Japan, 574-0074	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-8522	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Saino Clinic Tokorozawa, Japan, 359-1141	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Riverside Clinic Sapporo, Japan, 064-0807	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Toei Hospital sapporo, Japan, 007-0841	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Yoshida Memorial Hospital Sapporo, Japan, 003-0026	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Sapporo Century Hospital Sapporo, Japan, 003-0825	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kitano-dori Internal medicine and Cardiovascular medicine CL Sapporo, Japan, 062-0053	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kotoni Medical Support Clinic Sapporo, Japan, 063-0841	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kamagaya General Hospital Kamagaya, Japan, 273-0100	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Shizuoka Tokushukai Hospital Shizuoka, Japan, 421-0193	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Yao Tokushukai General Hospital Yao, Japan, 581-0011	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available

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:

Primary Outcome

Efficacy changes measured by sitting diastolic blood pressure (DBP)
Timeframe: Up to 8 weeks

Secondary Outcome

Efficacy changes measured by sitting systolic blood pressure (SBP)
Timeframe: Up to 8 weeks

Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Timeframe: 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
Timeframe: Up to 8 weeks

Hypertension

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

20 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information