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

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ClinicalTrials.gov Identifier: NCT00768560
Recruitment Status : Completed
First Posted : October 8, 2008
Results First Posted : February 2, 2010
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD Phase 2

Detailed Description:
Issues on safety are addressed in the Adverse Event section.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.
Study Start Date : January 2008
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Nifedipine (Adalat CR, BAYA1040) 40 mg OD
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
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
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
Experimental: Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning


Outcome Measures

Primary Outcome Measures :
  1. Change of Sitting Blood Pressure [ Time Frame: 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 :
  1. Differences of Systolic Blood Pressure Profile [ Time Frame: 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)

  2. Differences of Diastolic Blood Pressure Profile [ Time Frame: 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)

  3. Target Blood Pressure Achievement in Elderly (≥65) [ Time Frame: 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

  4. Target Blood Pressure Achievement in Non-elderly (<65) [ Time Frame: 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

  5. Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder [ Time Frame: After 2 weeks treatment ]
    Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg

  6. Target Blood Pressure Achievement in All Subjects [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768560


Locations
Japan
Sendai, Miyagi, Japan, 982-0032
Suita, Osaka, Japan, 565-0853
Koshigaya, Saitama, Japan, 343-0827
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00768560     History of Changes
Other Study ID Numbers: 13012
First Posted: October 8, 2008    Key Record Dates
Results First Posted: February 2, 2010
Last Update Posted: June 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs