Phase 2
N=35
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00768560 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Change of Sitting Blood Pressure — -10.19; -19.88; -10.13; -4.30 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nifedipine (Adalat CR, BAYA1040) 80mg OD (Drug); Nifedipine (Adalat CR, BAYA1040) 40mg BID (Drug); Nifedipine (Adalat CR, BAYA1040) 40mg OD (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Sitting Blood Pressure |
-10.19; -19.88; -10.13; -4.30; -8.28; -4.98 | — |
| SECONDARY Differences of Systolic Blood Pressure Profile |
-11.35; -21.24; -9.91; -4.91; -8.65; -11.97 | — |
| SECONDARY Differences of Diastolic Blood Pressure Profile |
-3.82; -8.12; -4.18; -4.15; -5.47; -7.18 | — |
| SECONDARY Target Blood Pressure Achievement in Elderly (≥65) |
2; 3; 3 | — |
| SECONDARY Target Blood Pressure Achievement in Non-elderly (<65) |
3; 10; 4 | — |
| SECONDARY Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder |
0; 4; 1 | — |
| SECONDARY Target Blood Pressure Achievement in All Subjects |
5; 17; 8 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00768560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.