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6R-BH4

Phase 2

Hypertension | Small molecule | Cardiovascular |BioMarin Pharmaceutical Inc.|Last Updated: Jul 21, 2009

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical trial landscape

6R-BH4 · 1 trial · 1 indication

Phase 2 1
NCT00325962A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic HypertensionHypertension
COMPLETED84 Analytics
PHASE2COMPLETED
A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension
Hypertension
NCT0032596284
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Study Endpoints
Primary Endpoints
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial systolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension.
Secondary Endpoints
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial diastolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in insulin sensitivity after 8 weeks of treatment in subjects with both type 2 diabetes and poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in eNOS activity and endothelial dysfunction after 8 weeks of treatment in subjects with poorly controlled hypertension
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
6R-BH4 (sapropterin dihydrochloride)DRUG -
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures. * At least 18 years of age. * Willing and able to comply with all study-related procedures. * History of documented essen...

Countries:United States
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Competitive Landscape -Hypertension 41 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS3PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
AstraZeneca PLCAZN2 - Undisclosed
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
Orchestra BioMed Holdings, Inc.OBIO3N/AUndisclosed
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
CVRx, Inc.CVRX1N/AMedical Management
Medtronic PlcMDT4N/AUndisclosed
IQVIA Holdings IncIQV1N/AUndisclosed
Verve Medical, IncVERV1N/AActive hypertension medical therapy
Tango Therapeutics, Inc.TNGX1N/ATriple Fixed-Dose Combination, Usual Care Antihypertensive Regimen
Harvard Bioscience, Inc.HBIO1 - Undisclosed
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