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ATACAND

Phase 3

Hypertension | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Aug 30, 2011

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00227318TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention TrialPHASE3 COMPLETED 1,000 — — Jul 1, 1998Oct 1, 2005Aug 30, 201142 United States
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Study Endpoints
Primary Endpoints
To determine whether candesartan cilexetil 16 mg compared to placebo reduces the crude incidence of hypertension in a population with high normal BP evaluated after a 4-year study period consisting of 2 years of double-blind treatment followed by 2 years
Secondary Endpoints
To evaluate the reduction in BP after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP.
To evaluate the incidence of hypertension after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP.
To evaluate Health-related Quality of Life yearly during 2 years treatment with candesartan cilexetil 16mg vs placebo and yearly during a 2-year follow up period in patients with high normal BP.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
PurposePREVENTION
Interventions
NameTypeDescription
ATACANDDRUG -
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Eligibility Criteria
Age Range30 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Subjects between the ages of 30 and 65 (inclusive) at the time of the informed consent process * have an average clinic BP in the high normal range of \< 139/85-89 mmHg or 130-139/\< 89 mm Hg (high normal BP range) (mean systolic and/or diastolic pressure based on 3 consecutiv...

Countries:United States
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Competitive Landscape -Hypertension 42 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron, LY3971297
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran, ALN-AGT01 RVR
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS3PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
AstraZeneca PLCAZN3 — Undisclosed
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
Novo Nordisk A/S Sponsored ADR Class BNVO1 — Undisclosed
Orchestra BioMed Holdings, Inc.OBIO3NAUndisclosed
CVRx, Inc.CVRX1NAMedical Management
Medtronic PlcMDT4NAUndisclosed
IQVIA Holdings IncIQV1NAUndisclosed
Verve Medical, IncVERV1NAActive hypertension medical therapy
Tango Therapeutics, Inc.TNGX1NATriple Fixed-Dose Combination, Usual Care Antihypertensive Regimen
Harvard Bioscience, Inc.HBIO1 — Undisclosed
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