Loading clinical trials...

A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) IN ADULTS WITH TYPE 2 DIABETES AND OVERT NEPHROPATHY

NCT01200394•Pfizer

View on ClinicalTrials.gov

Summary

PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.

Exclusion Criteria

•Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
•Subjects with poorly controlled diabetes mellitus, defined as HbA1C \>9%.
•Subjects on combination ACE inhibitor/ARB therapy.

Locations (160)

Saadat Ansari Internal Medicine

Huntsville, Alabama, United States

The Office of Iqbal Saeed MD, LLC

Huntsville, Alabama, United States

AKDHC Medical Research Services, LLC*

Glendale, Arizona, United States

Southwest Clinical Research Institute, LLC

Tempe, Arizona, United States

Southwest Clinical Research Institute, LLC

Tempe, Arizona, United States

North America Research Institute

Azusa, California, United States

North American Research Institute / California Kidney Specialist

Azusa, California, United States

Citrus Dialysis Center

Covina, California, United States

California Institute of Renal Research

La Mesa, California, United States

Capital Nephrology Clinical Research

Sacramento, California, United States

Key Dates

Start Date

December 1, 2010

Primary Completion Date

July 1, 2013

Completion Date

August 1, 2013

Last Updated

March 12, 2019

Enrollment

256

ACTUAL participants

Conditions

Diabetic Nephropathies

Interventions

PF-00489791

DRUG

Placebo

DRUG

Study of WAL0921 in Patients With Glomerular Kidney Diseases

NCT06466135

Diabetic NephropathiesPrimary Focal Segmental Glomerulosclerosis+3 more

View study

RECRUITINGPHASE2/PHASE3

Clinical Outcome of Vinpocetine in Diabetic Nephropathy

NCT06441591

Diabetic Kidney DiseaseDiabetic Nephropathies

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

Inclusion Criteria

Exclusion Criteria

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Clinical Outcome of Vinpocetine in Diabetic Nephropathy

Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes

Effect of High-intensity Laser Exercise Versus Moderate-intensity Aerobic Exercise on Diabetic Polyneuropathy Patients

Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia

PERL Continuous Glucose Monitoring (CGM) Study