Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study

Bayer

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID; Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD; Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768560

13012

Details and patient eligibility

About

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).

Full description

Issues on safety are addressed in the Adverse Event section.

Enrollment: 35 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups

Nifedipine (Adalat CR, BAYA1040) 40 mg OD

Active Comparator group

Description:

Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning

Treatment:

Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD

Nifedipine (Adalat CR, BAYA1040) 40 mg BID

Experimental group

Description:

Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening

Treatment:

Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID

Nifedipine (Adalat CR, BAYA1040) 80 mg OD

Experimental group

Description:

Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning

Treatment:

Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD