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Nifedipine OD

Phase 2

Hypertension | Small molecule | Cardiovascular |Bayer AG|Last Updated: Jun 8, 2015

Target and mechanism

ModalitySmall molecule

Also known as Nifedipine (Adalat CR, BAYA1040) 80mg OD

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

Nifedipine OD · 1 trial · 1 indication

Phase 2 1
NCT00768560Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD StudyHypertension
COMPLETED35 Analytics
PHASE2COMPLETED
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Differences of Systolic Blood Pressure Profile
Baseline and after 2 weeks treatment
Differences of Diastolic Blood Pressure Profile
Baseline and after 2 weeks treatment
Target Blood Pressure Achievement in Elderly (≥65)
After 2 weeks treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Nifedipine (Adalat CR, BAYA1040) 40 mg ODACTIVE_COMPARATORNifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40 mg BIDEXPERIMENTALNifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Nifedipine (Adalat CR, BAYA1040) 80 mg ODEXPERIMENTALNifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning

Interventions

NameTypeDescription
Nifedipine (Adalat CR, BAYA1040) 80mg ODDRUGNifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40mg BIDDRUGNifedipine (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 ODDRUGNifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

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) \>= 160mm...

Countries:Japan
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