Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-00489791 · 3 trials · 4 indications
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| PF-00489791 | EXPERIMENTAL | - |
| Placebo | PLACEBO_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 mg | EXPERIMENTAL | - |
| PF-00489791 4 mg | EXPERIMENTAL | - |
| PF-00489791 10 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-00489791 | DRUG | Tablet, 20 mg once daily for 12 weeks |
| Placebo | DRUG | Tablet, placebo once daily for 12 weeks |
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...
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.
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.
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.
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.
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.