Study Completed

Hypertension

Bayer Identifier:

13176

ClinicalTrials.gov Identifier:

NCT01287260

EudraCT Number:

Not Available

EU CT Number:

Not Available

High Dose BAYA1040_Nifedipine: a dose-comparative study

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A

Trial summary

Enrollment Goal

352

Trial Dates

January 2011 - August 2011

Phase

Phase 3

Could I Receive a placebo

Products

Adalat CC (Nifedipine, BAYA1040)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Kihara Cardiovascular and Internal Hospital	Asahikawa, 078-8214, Japan
Completed	Kunimoto Hospital	Asahikawa, 070-0061, Japan
Completed	Shinsapporo Seiryo Hospital	Sapporo, 004-0004, Japan
Completed	Maruyama Rira Clinic	Sapporo, 064-0803, Japan
Completed	Close To You EST Clinic	Hirosaki, 036-8082, Japan
Completed	Shinagawa East One Medical Clinic	Minato, 108-0075, Japan
Completed	Pedi-Shiodome Clinic	Minato, 105-7390, Japan
Completed	Nishimura Internal Cardiovascular Clinic	Meguro, 152-0031, Japan
Completed	NS Clinic	Hachioji, 192-0046, Japan
Completed	Koukan Clinic	Kawasaki, 210-0852, Japan
Completed	Nozaki Tokushukai Hospital	Daito, 574-0074, Japan
Completed	Kishiwada Tokushukai Hospital	Kishiwada, 596-8522, Japan
Terminated	Saino Clinic	Tokorozawa, 359-1141, Japan
Completed	Riverside Clinic	Sapporo, 064-0807, Japan
Completed	Toei Hospital	sapporo, 007-0841, Japan
Completed	Yoshida Memorial Hospital	Sapporo, 003-0026, Japan
Completed	Sapporo Century Hospital	Sapporo, 003-0825, Japan
Completed	Kitano-dori Internal medicine and Cardiovascular medicine CL	Sapporo, 062-0053, Japan
Completed	Kotoni Medical Support Clinic	Sapporo, 063-0841, Japan
Completed	Kamagaya General Hospital	Kamagaya, 273-0100, Japan
Completed	Shizuoka Tokushukai Hospital	Shizuoka, 421-0193, Japan
Completed	Yao Tokushukai General Hospital	Yao, 581-0011, Japan

Primary Outcome

Efficacy changes measured by sitting diastolic blood pressure (DBP)
Time Frame:
Up to 8 weeks
Safety Issue:
No

Secondary Outcome

Efficacy changes measured by sitting systolic blood pressure (SBP)
Time Frame:
Up to 8 weeks
Safety Issue:
No
Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Time Frame:
Up to 8 weeks
Safety Issue:
No
Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Time Frame:
Up to 8 weeks
Safety Issue:
No

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

Additional Information

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