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High Dose BAYA1040_Nifedipine: a Dose-comparative Study

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nifedipine (Adalat, BAYA1040) (Drug); Nifedipine (Adalat, BAYA1040) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Efficacy changes measured by sitting diastolic blood pressure (DBP)

Secondary outcome:

Efficacy changes measured by sitting systolic blood pressure (SBP)

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

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

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Shizuoka 421-0193, Japan

Hirosaki, Aomori 036-8082, Japan

Kamagaya, Chiba 273-0100, Japan

Asahikawa, Hokkaido 070-0061, Japan

Asahikawa, Hokkaido 078-8214, Japan

Sapporo, Hokkaido 007-0841, Japan

Sapporo, Hokkaido 003-0825, Japan

Sapporo, Hokkaido 004-0004, Japan

Sapporo, Hokkaido 003-0026, Japan

Sapporo, Hokkaido 062-0053, Japan

Sapporo, Hokkaido 063-0841, Japan

Sapporo, Hokkaido 064-0803, Japan

Sapporo, Hokkaido 064-0807, Japan

Kawasaki, Kanagawa 210-0852, Japan

Daito, Osaka 574-0074, Japan

Kishiwada, Osaka 596-8522, Japan

Yao, Osaka 581-0011, Japan

Tokorozawa, Saitama 359-1141, Japan

Hachioji, Tokyo 192-0046, Japan

Meguro, Tokyo 152-0031, Japan

Minato, Tokyo 105-7390, Japan

Minato, Tokyo 108-0075, Japan

Additional Information

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Starting date: January 2011
Last updated: January 28, 2014

Page last updated: August 23, 2015

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