check_circleStudy Completed

Hypertension

Bayer Identifier:

13012

ClinicalTrials.gov Identifier:

NCT00768560

EudraCT Number:

Not Available

EU CT Number:

Not Available
Nifedipine (Adalat CR, BAY A1040) high dose PK/PD study

Trial purpose

This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR tablet 40 mg and its placebo as follows (Double-blind treatment period).

Key Participants Requirements

Sex

Both

Age

20 - 75 Years
  • - Male and female
    - 20 years or older and less than 75 years
    - Outpatient
    - Untreated or treated patients with
    antihypertensive agents whose blood pressure (BP) in sitting
    position at entry (Visit 1) is as follows.
     -- Untreated patients: systolic blood pressure (SBP) >= 160mmHg or
    diastolic blood pressure (DBP) >= 100mmHg
     -- Treated patients: SBP >= 140mmHg or
    DBP >= 90mmHg (at trough)
  • - Patients whose BP during baseline treatment
    period is: SBP>=200mmHg or DBP>=120mmHg.
    - Patients with secondary hypertension or
    hypertensive emergency.
    - Patients with cardiovascular or
    cerebrovascular ischemic event (stroke, transient ischemic attack (TIA),
    myocardial infarction or unstable angina), or
    with history of these within 6 months prior to
    the study.
    - Patients with intracranial or subarachnoid
    hemorrhage, or with history of these within 6
    months prior to the study.
    - Patients with server hematopoietic dysfunction
    (acute/chronic leukemia, myeloma, malignant
    lymphoma, myelodysplastic syndrome, aplastic
    anemia), or with history of these.

Trial summary

Enrollment Goal
35
Trial Dates
January 2008 - May 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Adalat CC (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Taihaku Sakura HospitalSendai, 982-0032, Japan
Completed
Aiwa ClinicKoshigaya, 343-0827, Japan
Completed
OCROM ClinicSuita, 565-0853, Japan

Primary Outcome

  • Change of Sitting Blood Pressure
    date_rangeTime Frame:
    Baseline and after 2 weeks treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Differences of Systolic Blood Pressure Profile
    date_rangeTime Frame:
    Baseline and after 2 weeks treatment
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    Safety Issue:
    No
  • Differences of Diastolic Blood Pressure Profile
    date_rangeTime Frame:
    Baseline and after 2 weeks treatment
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    Safety Issue:
    No
  • Target Blood Pressure Achievement in Elderly (≥65)
    date_rangeTime Frame:
    After 2 weeks treatment
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    Safety Issue:
    No
  • Target Blood Pressure Achievement in Non-elderly (<65)
    date_rangeTime Frame:
    After 2 weeks treatment
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    Safety Issue:
    No
  • Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder
    date_rangeTime Frame:
    After 2 weeks treatment
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    Safety Issue:
    No
  • Target Blood Pressure Achievement in All Subjects
    date_rangeTime Frame:
    After 2 weeks treatment
    enhanced_encryption
    Safety Issue:
    No

Trial design

Evaluation of the efficacy, safety, and pharmacokinetics/pharmacodynamics of BAY A1040 CR tablet on high dose administration in patients with essential hypertension.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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