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rolofylline

Phase 3

Heart Failure, Congestive | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Oct 20, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment2,514

FDA Designations

No designations recorded

Clinical trial landscape

rolofylline · 4 trials · 2 indications

Phase 3 3Phase 2 1
NCT00443690Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring IV TherapyHeart Failure, Congestive
COMPLETED480 Analytics
NCT00354458PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal FunctionHeart Failure, Congestive
COMPLETED1,102 Analytics
NCT00328692PROTECT-1: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal FunctionHeart Failure, Congestive
COMPLETED932 Analytics
PHASE3COMPLETED
Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring IV Therapy
Heart Failure, Congestive
NCT00443690480
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PHASE3COMPLETED
PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function
Heart Failure, Congestive
NCT003544581,102
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PHASE3COMPLETED
PROTECT-1: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function
Heart Failure, Congestive
NCT00328692932
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Study Endpoints

Primary Endpoints

Effect on heart failure signs and symptoms
through day 7
Effect on renal function
through Day 7
change in pulmonary capillary wedge pressure
from baseline to 4 and 8 hours

Secondary Endpoints

safety
3 Days
within trial medical costs compared to placebo
3 Days
Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure
from baseline to 4 and 8 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
2PLACEBO_COMPARATORplacebo control
1EXPERIMENTALKW-3902IV

Interventions

NameTypeDescription
rolofyllineDRUGrolofylline 30 mg IV QD; 3 days
Comparator: Placebo (unspecified)DRUGrolofylline Pbo 30 mg IV QD; 3 days
Comparator: PlaceboDRUGrolofylline placebo IV infusion over 4 hours.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Dyspnea at rest or with minimal exertion at randomization * Fluid overload * Estimated creatinine clearance (CrCl) between 20-60 mL/min * Worsening renal function * Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug * BNP \>500 pg/mL...

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Frequently asked questions about rolofylline

What is rolofylline used for?

Rolofylline is an investigational small molecule being developed for the treatment of heart failure, including congestive heart failure. It was studied in patients hospitalized with acute heart failure and volume overload, as well as in those with worsening renal function and heart failure requiring intravenous therapy.

What does rolofylline target?

Rolofylline is a selective A1 adenosine receptor antagonist. By blocking the A1 adenosine receptor, it is designed to affect congestion and renal function in patients with heart failure. This mechanism was evaluated in clinical trials for its potential to improve outcomes in this patient population.

Who makes rolofylline?

Rolofylline is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company sponsored clinical trials of the drug for heart failure indications, including studies in patients with acute heart failure and volume overload.

What phase is rolofylline in?

Rolofylline has completed Phase 2 and Phase 3 clinical trials. The drug is investigational and has not been approved by regulatory authorities. All four completed trials, including three Phase 3 studies, have finished, and no active trials are currently listed.

What clinical trials is rolofylline in?

Rolofylline has been studied in several completed trials. These include NCT00328692 (PROTECT-1), NCT00354458 (PROTECT-2), and NCT00443690, all Phase 3 trials in patients with congestive heart failure, and NCT00729222, a Phase 2 trial in heart failure patients. Total enrollment across these studies was 2,514 participants.

Is rolofylline the same as KW-3902?

Yes, rolofylline is also known as KW-3902. Clinical trial titles, such as PROTECT-1 and PROTECT-2, refer to the drug as KW-3902, a selective A1 adenosine receptor antagonist. This alternative name appears in studies of patients hospitalized with acute heart failure and volume overload.