Trial Condition(s):

Hypertension

Nifedipine (Adalat CR, BAY A1040) high dose PK/PD study

Bayer Identifier:

13012

ClinicalTrials.gov Identifier:

NCT00768560

EudraCT Number:

Not Available

Study Completed

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).

Inclusion Criteria
- 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)
Exclusion Criteria
- 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
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Adalat CC (Nifedipine, BAYA1040)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Taihaku Sakura Hospital

Sendai, Japan, 982-0032

Status
Completed
 
Locations

Aiwa Clinic

Koshigaya, Japan, 343-0827

Status
Completed
 
Locations

OCROM Clinic

Suita, Japan, 565-0853

Status
Completed
 

Trial Design