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Candesartan

Phase 3

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

Target and mechanism

ModalitySmall molecule

Also known as Candesartan (test)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment7,599

FDA Designations

No designations recorded

Clinical trial landscape

Candesartan · 8 trials · 8 indications

Phase 3 6Phase 2 1Phase 1 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
Hypertension
NCT004349672,207
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PHASE3COMPLETED
DIabetic Retinopathy Candesartan Trials
Type 2 Diabetes
NCT002526944,717
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PHASE3COMPLETED
DIabetic Retinopathy Candesartan Trials.
Type 1 Diabetes
NCT002527201,850
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PHASE3COMPLETED
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Added)
Congestive Heart Failure
NCT00634309597
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PHASE3COMPLETED
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)
Congestive Heart Failure
NCT00634712734
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PHASE3COMPLETED
Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)
Congestive Heart Failure
NCT006344006,268
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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
Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®.
76 blood samples per subject

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 -
Single-armOTHER3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)

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
Candesartan (test)DRUG16 mg oral tablet, single dose
Felodipine (test)DRUG5 mg oral extended release tablet, single dose
FelodipineDRUG5 mg oral extended release tablet, single dose
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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:BelgiumLatviaMaltaRomaniaRussiaSlovakiaNorwayBrazil
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