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High Dose BAYA1040_Nifedipine: a Long Term Combination Study

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ClinicalTrials.gov Identifier: NCT01294215
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Nifedipine (Adalat, BAYA1040) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Nifedipine (Adalat, BAYA1040)
Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID)



Primary Outcome Measures :
  1. Efficacy changes measured by sitting diastolic blood pressure (DBP) [ Time Frame: Up to 52 weeks ]

Secondary Outcome Measures :
  1. Efficacy changes measured by sitting systolic blood pressure (SBP) [ Time Frame: Up to 52 weeks ]
  2. Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines [ Time Frame: Up to 52 weeks ]
  3. 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 ]
  4. Safety variables [ Time Frame: Up to 30 days after the last dose of study drug ]
    Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01294215     History of Changes
Other Study ID Numbers: 14024
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

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
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs