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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00768560
First received: October 7, 2008
Last updated: May 25, 2014
Last verified: May 2014

October 7, 2008
May 25, 2014
January 2008
May 2008   (final data collection date for primary outcome measure)
Change of Sitting Blood Pressure [ Time Frame: Baseline and after 2 weeks treatment ] [ Designated as safety issue: No ]
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])
Change of sitting SBP and DBP (trough values) from baseline [ Time Frame: Visit 2, 3, 4, 5 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00768560 on ClinicalTrials.gov Archive Site
  • Differences of Systolic Blood Pressure Profile [ Time Frame: Baseline and after 2 weeks treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and after 2 weeks treatment ] [ Designated as safety issue: No ]
    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 Elderly (≥65) [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
    Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg
  • Target Blood Pressure Achievement in Non-elderly (<65) [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
    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 Subjects With Diabetes Mellitus or Chronic Renal Disorder [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
    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 All Subjects [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
    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.
  • Differences of BP profile between at the end of each double-blind treatment period and baseline treatment period. [ Time Frame: Visit 2, 3, 4, 5 ] [ Designated as safety issue: No ]
  • Achievement (ratio) to the treatment target for BP at the end of double-blind treatment period. [ Time Frame: Visit 2, 3, 4, 5 ] [ Designated as safety issue: No ]
  • Incidence of drug-related adverse events. [ Time Frame: Visit 2, 3, 4, 5 ] [ Designated as safety issue: Yes ]
  • Incidence of all adverse events. [ Time Frame: Visit 2, 3, 4, 5 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.

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).

Issues on safety are addressed in the Adverse Event section.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD
    Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
  • 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
  • Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD
    Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
  • Active Comparator: Nifedipine (Adalat CR, BAYA1040) 40 mg OD
    Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
    Intervention: Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD
  • Experimental: 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
    Intervention: Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID
  • Experimental: Nifedipine (Adalat CR, BAYA1040) 80 mg OD
    Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
    Intervention: Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00768560
13012
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP