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Completed

NCT Number: NCT00768560

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

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).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sendai, Miyagi, Japan

Loading trial locations.

About this study

Issues on safety are addressed in the Adverse Event section.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nifedipine (Adalat CR, BAYA1040) 80mg OD

Drug

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

Nifedipine (Adalat CR, BAYA1040) 40mg BID

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) 40mg OD

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 8, 2008
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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