check_circleStudy Completed

Hypertension

Bayer Identifier:

14024

ClinicalTrials.gov Identifier:

NCT01294215

EudraCT Number:

Not Available

EU CT Number:

Not Available
High Dose BAYA1040_Nifedipine: a long term combination study

Trial 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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - 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
  • - Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
    - Patients with secondary hypertension or hypertensive emergency

Trial summary

Enrollment Goal
72
Trial Dates
February 2011 - June 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
Adalat CC (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sugiura IinKawaguchi, 332-0012, Japan
Completed
Sagamino Central HospitalEbina, 243-0401, Japan
Completed
Oda ClinicShinjuku, 169-0072, Japan
Completed
Yamamoto ClinicSagamihara, 252-0311, Japan

Primary Outcome

  • Efficacy changes measured by sitting diastolic blood pressure (DBP)
    date_rangeTime Frame:
    Up to 52 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Efficacy changes measured by sitting systolic blood pressure (SBP)
    date_rangeTime Frame:
    Up to 52 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
    date_rangeTime Frame:
    Up to 52 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
    date_rangeTime Frame:
    Up to 52 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Safety variables
    Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.
    date_rangeTime Frame:
    Up to 30 days after the last dose of study drug
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.