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ISIS CRP Rx

Phase 2

Paroxysmal Atrial Fibrillation | Small molecule | Cardiovascular |Ionis Pharmaceuticals, Inc.|Last Updated: Aug 26, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

ISIS CRP Rx · 1 trial · 1 indication

Phase 2 1
NCT01710852Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial FibrillationParoxysmal Atrial Fibrillation
COMPLETED7 Analytics
PHASE2COMPLETED
Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial FibrillationUnlock trial analytics

Study Endpoints

Primary Endpoints

AF burden reduction
113 Days

Burden measured as percentage of time spent in AF as derived from continuous pacemaker monitoring

Secondary Endpoints

To assess the effect of ISIS CRP Rx on the:
113 Days
To assess the effect of ISIS CRP Rx on ventricular rate during sinus rhythm
113 Days
To assess the effect of ISIS CRP Rx on measures of Quality of Life
113 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALISIS CRP Rx followed by Placebo
Group BEXPERIMENTALPlacebo followed by ISIS CRP Rx

Interventions

NameTypeDescription
ISIS CRP RxDRUG -
PlaceboDRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Male of female; age over 18 years * Dual chamber permanent pacemaker implanted * Confirmed diagnosis of paroxysmal atrial fibrillation with an AF burden of 1 to 50%, as derived from pacemaker diagnostic algorithms * Able to have pacemaker antiarrhythmic algorithms turned off f...

Countries:United Kingdom
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Frequently asked questions about ISIS CRP Rx

What is ISIS CRP Rx used for?

ISIS CRP Rx is an investigational drug being studied for the treatment of paroxysmal atrial fibrillation, a type of irregular heartbeat that comes and goes. It is in Phase 2 clinical development for this cardiovascular condition.

How does ISIS CRP Rx work?

ISIS CRP Rx is a small molecule designed to target C-reactive protein (CRP), a marker of inflammation. By reducing CRP levels, it may help reduce inflammation that contributes to atrial fibrillation episodes. The exact mechanism is being evaluated in clinical trials.

Who is developing ISIS CRP Rx?

ISIS CRP Rx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical research to evaluate the drug's safety and efficacy.

What phase is ISIS CRP Rx in?

ISIS CRP Rx is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial has been completed to assess its effects in patients with paroxysmal atrial fibrillation.

What clinical trials has ISIS CRP Rx been in?

ISIS CRP Rx has been studied in a Phase 2 clinical trial registered as NCT01710852, titled 'Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation.' This randomized, double-blind, controlled trial enrolled 7 participants in the United Kingdom and has been completed.

Is ISIS CRP Rx the same as other drugs?

ISIS CRP Rx is a specific investigational compound developed by Ionis Pharmaceuticals. It is not known to be marketed under any other names. Its development name reflects its targeting of C-reactive protein (CRP) for potential therapeutic use.