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HCTZ monotherapy

Phase 3

Hypertension | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Apr 15, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment496
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00095550Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate HypertensionPHASE3 COMPLETED 496Oct 1, 2004Jun 1, 2005Apr 15, 2011128 United States, Canada +3
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Study Endpoints
Primary Endpoints
Change from baseline in SeSBP at Week 8
Secondary Endpoints
Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A1EXPERIMENTAL -
A2ACTIVE_COMPARATOR -
A3ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Irbesartan/HCTZDRUGTablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.
Irbesartan monotherapyDRUGTablets, Oral, 150 mg, Once daily, 12 weeks.
HCTZ monotherapyDRUGTablets, Oral, 12.5 mg, Once daily, 12 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites128

Inclusion Criteria: * Willing to provide written informed consent * Subjects must have uncontrolled hypertension defined as: * average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or * average diastolic blood pressure between 100 ...

Countries:United StatesCanadaFranceGermanyRussia
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