Status:
COMPLETED
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
Lead Sponsor:
Bayer
Conditions:
Hypertension
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
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 (co...
Detailed Description
Issues on safety are addressed in the Adverse Event section.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00768560
Start Date
January 1 2008
End Date
May 1 2008
Last Update
June 8 2015
Active Locations (3)
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1
Sendai, Miyagi, Japan, 982-0032
2
Suita, Osaka, Japan, 565-0853
3
Koshigaya, Saitama, Japan, 343-0827