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Renal sympathetic denervation

Phase 3

Hypertension | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Feb 1, 2017

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since May 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

Renal sympathetic denervation · 1 trial · 2 indications

Phase 3 1
NCT01850901Renal Sympathetic Denervation as a New Treatment for Therapy Resistant HypertensionHypertension
COMPLETED139 Analytics
PHASE3COMPLETED
Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension
Hypertension
NCT01850901139
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Study Endpoints

Primary Endpoints

Change in BP (measured by ABPM)
6 months

Change in BP: average day-time systolic blood pressure (SBP) as determined with the use of ambulatory blood pressure-monitoring at 6 months and during prolonged follow up (total 2 years)

Secondary Endpoints

Change in the amount of antihypertensive medication
6 months
Change in BP in eGFR strata
6 months
Change in office BP
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Renal sympathetic denervationEXPERIMENTALCatheter-based renal nerve ablation
Usual careNO_INTERVENTIONAntihypertensive treatment according to guidelines

Interventions

NameTypeDescription
Renal sympathetic denervationPROCEDURE -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Individual has a mean day-time SBP ≥ 135 mmHg, as determined with the use of ABPM, while using 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs ( ACE/ARB, Calci...

Countries:Netherlands
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Competitive Landscape -Hypertension 40 trials

Top 7 of 14 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY3PHASE3Orforglipron
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran, ALN-AGT01 RVR
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS2PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
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