High Dose BAYA1040_Nifedipine: a Long Term Combination Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01294215
First received: February 10, 2011
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.


Condition Intervention Phase
Hypertension
Drug: Nifedipine (Adalat, BAYA1040)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Efficacy changes measured by sitting diastolic blood pressure (DBP) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy changes measured by sitting systolic blood pressure (SBP) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
  • 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 52 weeks ] [ Designated as safety issue: No ]
  • Safety variables [ Time Frame: Up to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.


Enrollment: 72
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nifedipine (Adalat, BAYA1040)
Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 years or older
  • Japanese male or female
  • Outpatient with essential hypertension
  • Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study

Exclusion Criteria:

  • Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
  • Patients with secondary hypertension or hypertensive emergency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294215

Locations
Japan
Ebina, Kanagawa, Japan, 243-0401
Sagamihara, Kanagawa, Japan, 252-0311
Kawaguchi, Saitama, Japan, 332-0012
Shinjuku, Tokyo, Japan, 169-0072
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01294215     History of Changes
Other Study ID Numbers: 14024
Study First Received: February 10, 2011
Last Updated: June 20, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
BAYA1040
Nifedipine
Essential hypertension
Japanese Patients
Phase III
combination study
14024

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014