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Nifedipine/Candesartan

Phase 3

Hypertension | Small molecule | Cardiovascular |Bayer AG|Last Updated: Dec 10, 2015

Target and mechanism

ModalitySmall molecule

Also known as Nifedipine (Adalat CR, BAYA1040) 40mg BID, Nifedipine, Nifedipine (Adalat, BAYA1040)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials3
Total Enrollment544

FDA Designations

No designations recorded

Clinical trial landscape

Nifedipine/Candesartan · 4 trials · 2 indications

Phase 3 3Phase 1 1
NCT01294215High Dose BAYA1040_Nifedipine: a Long Term Combination StudyHypertension
COMPLETED72 Analytics
NCT01287260High Dose BAYA1040_Nifedipine: a Dose-comparative StudyHypertension
COMPLETED352 Analytics
NCT01355367High Dose BAYA1040 CR: a Long Term Extension StudyHypertension
COMPLETED120 Analytics
PHASE3COMPLETED
High Dose BAYA1040_Nifedipine: a Long Term Combination Study
HypertensionUnlock trial analytics
PHASE3COMPLETED
High Dose BAYA1040_Nifedipine: a Dose-comparative Study
HypertensionUnlock trial analytics
PHASE3COMPLETED
High Dose BAYA1040 CR: a Long Term Extension Study
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy changes measured by sitting diastolic blood pressure (DBP)
Up to 52 weeks
Safety variables will be summarized using descriptive statistics based on adverse events collection
Week 52
Cmax
within 48 hours after each dosing

Maximum drug concentration in plasma after dose administration for nifedipine and candesartan

AUC(0-tlast)
within 48 hours after each dosing

Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartan

Secondary Endpoints

Efficacy changes measured by sitting systolic blood pressure (SBP)
Up to 52 weeks
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Up to 52 weeks
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Up to 52 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -
Nifedipine/Candesartan (fixed dose)EXPERIMENTAL -
Nifedipine/Candesartan (loose)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Nifedipine (Adalat, BAYA1040)DRUGNifedipine (Adalat, BAYA1040) 40mg twice a day (BID)
Nifedipine/Candesartan (BAY 98-7106)DRUGFixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)DRUGLoose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * 20 years or older * Japanese male or female * Outpatient with essential hypertension * Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study Exclusion Criteria: * Pat...

Countries:JapanGermany
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