Trial Condition(s):
Hypertension
Nifedipine (Adalat CR, BAY A1040) high dose PK/PD study
Bayer Identifier:
13012
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Taihaku Sakura Hospital Sendai, Japan, 982-0032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aiwa Clinic Koshigaya, Japan, 343-0827 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OCROM Clinic Suita, Japan, 565-0853 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Change of Sitting Blood PressureTimeframe: Baseline and after 2 weeks treatment
Secondary Outcome
- Differences of Systolic Blood Pressure ProfileTimeframe: Baseline and after 2 weeks treatment
- Differences of Diastolic Blood Pressure ProfileTimeframe: Baseline and after 2 weeks treatment
- Target Blood Pressure Achievement in Elderly (≥65)Timeframe: After 2 weeks treatment
- Target Blood Pressure Achievement in Non-elderly (<65)Timeframe: After 2 weeks treatment
- Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal DisorderTimeframe: After 2 weeks treatment
- Target Blood Pressure Achievement in All SubjectsTimeframe: After 2 weeks treatment
Additional Information
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