Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-00489791 · 4 trials · 5 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.
AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
| 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 | - |
| Treatment B | EXPERIMENTAL | Treatment B subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of itraconazole (200 mg once daily). |
| Treatment C | EXPERIMENTAL | Treatment C subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of diltiazem (240 mg once daily). |
| Treatment D | EXPERIMENTAL | Treatment D subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of verapamil (240 mg once daily). |
| Name | Type | Description |
|---|---|---|
| PF-00489791 | DRUG | Tablet, 20 mg once daily for 12 weeks |
| Placebo | DRUG | Tablet, placebo once daily for 12 weeks |
| itraconazole | DRUG | itraconazole dosed at 200 mg |
| diltiazem | DRUG | diltiazem dosed at 240 mg |
| SR verapamil | DRUG | SR verapamil dosed at 240 mg |
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 being studied for diabetic nephropathies, Raynaud's disease, and hypertension. It has been evaluated in clinical trials for these conditions, including in patients with type 2 diabetes and overt nephropathy, as well as in healthy volunteers for pharmacokinetic studies.
PF-00489791 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug has been studied in Phase 2 clinical trials sponsored by Pfizer.
PF-00489791 has completed Phase 2 clinical trials for diabetic nephropathies, Raynaud's disease, and hypertension. It is an investigational drug and has not been approved by regulatory authorities. Its development status is based on completed trials, with no ongoing active trials listed.
PF-00489791 has been studied in several completed trials, including NCT00422461 for hypertension, NCT01090492 for Raynaud's disease, NCT01200394 for diabetic nephropathies, and NCT02319148 in healthy volunteers. These trials were Phase 1 or Phase 2, placebo-controlled, and randomized.
PF-00489791 is the primary name used for this drug in clinical trials and publications. No alternative names have been identified in the available information, so it is consistently referred to by this identifier across studies.