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

NCT ID: NCT00768560

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-05-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nifedipine (Adalat CR, BAYA1040) 40 mg OD

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

Group Type: ACTIVE_COMPARATOR

Nifedipine (Adalat CR, BAYA1040) 40mg OD

Intervention Type: DRUG

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

Nifedipine (Adalat CR, BAYA1040) 40 mg BID

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

Group Type: EXPERIMENTAL

Nifedipine (Adalat CR, BAYA1040) 40mg BID

Intervention Type: DRUG

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

Nifedipine (Adalat CR, BAYA1040) 80 mg OD

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

Group Type: EXPERIMENTAL

Nifedipine (Adalat CR, BAYA1040) 80mg OD

Intervention Type: DRUG

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

Interventions

Nifedipine (Adalat CR, BAYA1040) 80mg OD

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

Intervention Type: DRUG

Nifedipine (Adalat CR, BAYA1040) 40mg BID

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

Intervention Type: DRUG

Nifedipine (Adalat CR, BAYA1040) 40mg OD

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Sendai, Miyagi, Japan

Suita, Osaka, Japan

Koshigaya, Saitama, Japan

Countries

Japan

Other Identifiers

13012

Identifier Type: -

Identifier Source: org_study_id