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

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID; Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD; Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD

• Registration Number: NCT00768560
• Lead Sponsor: Bayer

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Results First Submitted: 2009-09-28
• Results First Submitted QC: 2010-01-07
• Results First Posted: 2010-02-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nifedipine (Adalat CR, BAYA1040) 40 mg BID	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) 40 mg OD	Nifedipine (Adalat CR, BAYA1040) 40mg OD	Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 80 mg OD	Nifedipine (Adalat CR, BAYA1040) 80mg OD	Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning

Primary Outcome Measures

Name	Time	Method
Change of Sitting Blood Pressure	Baseline and after 2 weeks treatment	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 \[trough BP at the end of the baseline treatment period\])

Secondary Outcome Measures

Name	Time	Method
Target Blood Pressure Achievement in All Subjects	After 2 weeks treatment	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.
Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder	After 2 weeks treatment	Subjects with diabetes mellitus or chronic renal disorders and target BP SBP \<130 mm Hg and DBP \<80 mm Hg
Differences of Systolic Blood Pressure Profile	Baseline and after 2 weeks treatment	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)
Differences of Diastolic Blood Pressure Profile	Baseline and after 2 weeks treatment	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)
Target Blood Pressure Achievement in Non-elderly (<65)	After 2 weeks treatment	Non-elderly subjects (\<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP \<130 mm Hg and DBP \<85 mm Hg
Target Blood Pressure Achievement in Elderly (≥65)	After 2 weeks treatment	Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP \<140 mm Hg and DBP \<90 mm Hg