Clinical trial NCT00768560: Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
Official title: Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 (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).

Detailed description: Issues on safety are addressed in the Adverse Event section.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Sitting Blood Pressure
timeFrame: Baseline and after 2 weeks treatment
Secondary outcomes:
measure: Differences of Systolic Blood Pressure Profile
timeFrame: Baseline and after 2 weeks treatment
measure: Differences of Diastolic Blood Pressure Profile
timeFrame: Baseline and after 2 weeks treatment
measure: Target Blood Pressure Achievement in Elderly (≥65)
timeFrame: After 2 weeks treatment
measure: Target Blood Pressure Achievement in Non-elderly (<65)
timeFrame: After 2 weeks treatment
measure: Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder
timeFrame: After 2 weeks treatment
measure: Target Blood Pressure Achievement in All Subjects
timeFrame: After 2 weeks treatment
Other outcomes:
Locations:
city: Sendai
country: Japan
state: Miyagi
city: Suita
country: Japan
state: Osaka
city: Koshigaya
country: Japan
state: Saitama
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: