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

Hypertension Clinical Trial

Official title:

Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768560
• Other study ID #: 13012
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2008
• Last updated: May 13, 2015
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: May 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Description:

Issues on safety are addressed in the Adverse Event section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Nifedipine (Adalat CR, BAYA1040) 80mg OD
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
• 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
• Nifedipine (Adalat CR, BAYA1040) 40mg OD
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Sitting Blood Pressure	Changes of sitting SBP and DBP (trough values) from baseline (ie [trough BP at the end of each period during the double-blind treatment period] minus [trough BP at the end of the baseline treatment period])	Baseline and after 2 weeks treatment	No
Secondary	Differences of Systolic Blood Pressure Profile	Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)	Baseline and after 2 weeks treatment	No
Secondary	Differences of Diastolic Blood Pressure Profile	Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)	Baseline and after 2 weeks treatment	No
Secondary	Target Blood Pressure Achievement in Elderly (=65)	Elderly subjects (=65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg	After 2 weeks treatment	No
Secondary	Target Blood Pressure Achievement in Non-elderly (<65)	Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg	After 2 weeks treatment	No
Secondary	Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder	Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg	After 2 weeks treatment	No
Secondary	Target Blood Pressure Achievement in All Subjects	Subjects (=65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg. Subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg.	After 2 weeks treatment	No

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