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PF-00489791

Phase 2

Diabetic Nephropathies | Small molecule | Nephrology |Pfizer, Inc.|Trials Updated: Oct 11, 2021

PF-00489791 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Jan 2007

PF-00489791 target and mechanism

Molecular targetPDE5A
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment634

FDA Designations

No designations recorded

PF-00489791 clinical trials

PF-00489791 · 3 trials · 4 indications

Phase 2 3
NCT01200394A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt NephropathyDiabetic Nephropathies
COMPLETED256 Analytics
NCT01090492PF-00489791 For The Treatment Of Raynaud'sRaynaud's Disease
COMPLETED243 Analytics
NCT00422461A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood PressureHypertension
COMPLETED135 Analytics
PHASE2COMPLETED
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Diabetic NephropathiesUnlock trial analytics
PHASE2COMPLETED
PF-00489791 For The Treatment Of Raynaud's
Raynaud's DiseaseUnlock trial analytics
PHASE2COMPLETED
A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12
Baseline, Week 12 (Day 5, 6, 7)

UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \[Day 5, 6 of Week 12\], and with last sample collected on the morning of scheduled clinic visit \[Day 7 of Week 12\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.

Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
Baseline, Week 4

The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.

Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28
From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28

The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean daytime SBP was an average of SBP measurements taken between 08:00 and 16:00 hours by ABPM device on the specified time points. In this outcome measure change from baseline in mean daytime SBP at Day 28 is reported.

Secondary Endpoints

Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16
Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
Baseline, Week 3, 6, 12, 16 (follow-up)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-00489791EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Secondary Raynaud 4 mg dose (period 1)EXPERIMENTAL -
Secondary Raynaud 4 mg dose (period 2)EXPERIMENTAL -
Secondary Raynaud 20 mg dose (period 1)EXPERIMENTAL -
Secondary Raynaud 20 mg dose (period 2)EXPERIMENTAL -
Primary Raynaud 4 mg dose (period 1)EXPERIMENTAL -
Primary Raynaud 4 mg dose (period 2)EXPERIMENTAL -
Primary Raynaud 20 mg dose (period 1)EXPERIMENTAL -
Primary Raynaud 20 mg dose (period 2)EXPERIMENTAL -
PF-00489791 20 mg titrated to 40 mgEXPERIMENTAL -
PF-00489791 4 mgEXPERIMENTAL -
PF-00489791 10 mgEXPERIMENTAL -

Interventions

NameTypeDescription
PF-00489791DRUGTablet, 20 mg once daily for 12 weeks
PlaceboDRUGTablet, placebo once daily for 12 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites160

Inclusion Criteria: * Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential. * Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2. * Evidence of persistent, overt albuminuria...

Countries:United StatesAustraliaCanadaDenmarkHong KongIndiaMalaysiaMexicoPolandSerbiaSlovakiaSouth AfricaSouth KoreaSwedenUnited KingdomColombiaCzechiaGermanyHungarySpain
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Frequently asked questions about PF-00489791

What is PF-00489791 used for?

PF-00489791 is an investigational small molecule developed by Pfizer for diabetic nephropathy, hypertension, and Raynaud's disease. It has been studied in Phase 2 clinical trials for these conditions, including a placebo-controlled trial in patients with type 2 diabetes and overt nephropathy. It is not approved for any indication.

What does PF-00489791 target?

PF-00489791 targets PDE5A, also known as phosphodiesterase type 5, and acts as an inhibitor of this enzyme. By inhibiting PDE5A, the drug modulates the cGMP signaling pathway, which is relevant to vascular and renal function in the conditions studied.

Who makes PF-00489791?

PF-00489791 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating this compound in diabetic nephropathy, hypertension, and Raynaud's disease.

What phase is PF-00489791 in?

PF-00489791 is in Phase 2 clinical development. It has not been approved by the FDA or any regulatory agency for any indication. All trials conducted to date are Phase 2 studies, and no active trials are currently listed.

What clinical trials is PF-00489791 in?

PF-00489791 has been evaluated in three completed Phase 2 trials: NCT01200394 in type 2 diabetes with overt nephropathy, NCT01090492 in Raynaud's disease and peripheral vascular disease, and NCT00422461 in mild to moderate hypertension. All were randomized, double-blind, and placebo-controlled.