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Candesartan

Phase 4FDA approved 1998

Congestive Heart Failure | Small molecule | Cardiovascular |AstraZeneca PLC|Trials Updated: Jun 6, 2014

Candesartan development status

FDA approval Jun 4, 1998 as Atacand
Approval holderAni Pharms
ApplicationNDA020838
Highest phase Phase 4 (NCT00348686)
Phase scored for AZNPhase 3
Registered trials 19 across 11 sponsors since Aug 2005

Label indication Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) . Treatment of heart failure (NYHA class II-IV); FDA label

Candesartan target and mechanism

Molecular targetAGTR1
Target classAntagonist
ModalitySmall molecule

Also known as Candesartan (test), ATACAND

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials7
Total Enrollment16,445

FDA Designations

No designations recorded

Candesartan clinical trials

Candesartan · 7 trials · 7 indications

Phase 3 6Phase 2 1
NCT00434967Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and PlaceboHypertension
COMPLETED2,207 Analytics
NCT00252694DIabetic Retinopathy Candesartan TrialsType 2 Diabetes
COMPLETED4,717 Analytics
NCT00252720DIabetic Retinopathy Candesartan Trials.Type 1 Diabetes
COMPLETED1,850 Analytics
NCT00634309Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Added)Congestive Heart Failure
COMPLETED597 Analytics
NCT00634712Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)Congestive Heart Failure
COMPLETED734 Analytics
NCT00634400Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)Congestive Heart Failure
COMPLETED6,268 Analytics
PHASE3COMPLETED
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
HypertensionUnlock trial analytics
PHASE3COMPLETED
DIabetic Retinopathy Candesartan Trials
Type 2 DiabetesUnlock trial analytics
PHASE3COMPLETED
DIabetic Retinopathy Candesartan Trials.
Type 1 DiabetesUnlock trial analytics
PHASE3COMPLETED
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Added)
Congestive Heart FailureUnlock trial analytics
PHASE3COMPLETED
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)
Congestive Heart FailureUnlock trial analytics
PHASE3COMPLETED
Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)
Congestive Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).
8 weeks

Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.

Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)
8 weeks

Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.

Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale
From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.

3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.

Cardiovascular mortality or hospitalisation due to congestive heart failure
2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months
The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or is treated with the patient's usual headache medication
One year

Secondary Endpoints

The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study
8 weeks
Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP).
Baseline to 8 weeks
To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings.
Baseline to 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
4NO_INTERVENTIONPlacebo
2ACTIVE_COMPARATORCandesartan cilexetil
3ACTIVE_COMPARATORHydrochlorothiazide (HCT)
1EXPERIMENTALCandesartan cilexetil + Hydrochlorothiazide Combination
candesartanEXPERIMENTALcandesartan cilexetil 32 mg once daily
placeboNO_INTERVENTIONcontrol
1 CandesartanEXPERIMENTAL -
2 propranololACTIVE_COMPARATOR -
3 PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Candesartan cilexetilDRUG32 mg oral tablet
HydrochlorothiazideDRUG25 mg oral tablet
Candesartan/HCT 32/25 mgDRUG -
candesartanDRUG32 mg oral tablet
PlaceboDRUG -
propranololDRUGPropranolol hydrochloride capsules 160 mg once daily, slow release formulation
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Eligibility Criteria

Age Range20 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria: * Provision of signed Informed Consent * Primary hypertension, untreated or treated with a maximum of 2 antihypertensive drugs (substances), which the patient and the...

Countries:BelgiumLatviaMaltaRomaniaRussiaSlovakiaNorway
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Frequently asked questions about Candesartan

What is Candesartan used for?

Candesartan is studied for congestive heart failure, hypertension, migraine without aura, type 1 diabetes, and type 2 diabetes. It has been evaluated in Phase 3 trials for congestive heart failure and in a Phase 2 trial for migraine prevention. It is an investigational small molecule developed by AstraZeneca PLC.

What does Candesartan target?

Candesartan targets AGTR1, the angiotensin II type 1 receptor, and acts as an antagonist. By blocking this receptor, it inhibits angiotensin II signaling. This mechanism underlies its evaluation in cardiovascular and metabolic conditions such as congestive heart failure, hypertension, and diabetes.

Who makes Candesartan?

Candesartan is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is responsible for its clinical development across the studied indications.

What phase is Candesartan in?

Candesartan is in Phase 3 development. It has completed Phase 3 trials in congestive heart failure and a Phase 2 trial in migraine prevention. It is investigational and has not been approved by the FDA for the indications studied.

What clinical trials is Candesartan in?

Candesartan has been studied in completed trials including NCT00884663 (Phase 2, migraine prevention), NCT00634712 (Phase 3, CHARM Preserved), NCT00634400 (Phase 3, CHARM Alternative), and NCT00634309 (Phase 3, CHARM Added). These trials enrolled a total of 7,599 participants.