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Candesartan

Phase 3

Heart Failure | Small molecule | Cardiovascular |Takeda Pharmaceutical Company Limited|Last Updated: Jun 22, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

Candesartan · 1 trial · 1 indication

Phase 3 1
NCT00775840Efficacy of Candesartan on Symptomatic Heart Failure in Treating Diabetic and Hypertensive Patients.Heart Failure
COMPLETED22 Analytics
PHASE3COMPLETED
Efficacy of Candesartan on Symptomatic Heart Failure in Treating Diabetic and Hypertensive Patients.
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

The change from Baseline in N-terminal pro-B-type Natriuretic Peptide biomarker.
Week 24 or Final Visit.

Secondary Endpoints

Mean change in N-terminal pro-B-type Natriuretic Peptide (log-transformed).
Weeks 6 and 24 or Final Visit.
Change from Baseline in Short Form-36 Health Survey score.
Week 24 or Final Visit.
Change from Baseline in Cystatin C.
Week 24 or Final Visit.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Candesartan QD + Heart Failure TherapyEXPERIMENTAL(with angiotensin-converting enzyme-inhibitors/beta-blockers)
Placebo QD + Heart Failure TherapyPLACEBO_COMPARATOR(with angiotensin-converting enzyme-inhibitors/beta-blockers)

Interventions

NameTypeDescription
CandesartanDRUGCandesartan up to 32 mg, tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks.
PlaceboDRUGCandesartan matching-placebo tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks.
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Eligibility Criteria

Age Range45 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Diabetes mellitus type 2 - insulin dependent or orally treated or managed by diet for at least 3 Months. * Normotension or controlled hypertension with sitting Systolic Blood Pressure less than 140 mmHg and/or sitting Diastolic Blood Pressure less than 90 mmHg. * Regular sinus...

Countries:Germany
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