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candsartan cilexetil

Phase 3

Hypertension | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Dec 9, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment235
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00244595Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of AgePHASE3 COMPLETED 235Sep 1, 2003Nov 1, 2006Dec 9, 200944 United States, Belgium +2
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Study Endpoints
Primary Endpoints
- Achieved sitting, trough, systolic blood pressure summarized over time and at Week 52 & the mean of the last two measures.
- The measure of effect is the mean value and the corresponding descriptive statistics.
- Additional measures include mean diastolic blood pressure, and the proportion of subjects meeting 'controlled' criteria.
Secondary Endpoints
- Subject and baseline characteristics, antecedent treatment (eg, in 261A, an double-blind placebo-controlled efficacy study that is described elsewhere)
- The relationship to efficacy measures
- The relationship of antihypertensive treatment (candesartan cilexetil dose; add on therapy) and achieved blood pressure.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
candsartan cilexetilDRUG -
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Eligibility Criteria
Age Range6 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * The subjects must have fulfilled the eligibility criteria for and have participated in Study 261A or did not participate in Study 261A but meet the following criteria: * Diagnosed and untreated hypertension, or * Diagnosed and treated, but off antihypertensive treatment for at...

Countries:United StatesBelgiumHungarySlovakia
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