Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120328
Status:
TERMINATED
Last Update Posted:
2007-10-05
First Post:
2005-06-30
Brief Title:
To Determine the Effects of Avosentan on Doubling of Serum Creatinine End Stage Renal Disease and Death in Diabetic Nephropathy
Sponsor:
Speedel Pharma Ltd
Organization:
Speedel Pharma Ltd
Study Overview
Official Title:
ASCEND - A Randomised Double Blind Placebo Controlled Parallel Group Study to Assess the Effect of the Endothelin Receptor Antagonist Avosentan on Time to Doubling of Serum Creatinine End Stage Renal Disease or Death in Patients With Type 2 Diabetes Mellitus and Diabetic Nephropathy
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether avosentan SPP301 is effective in decreasing morbidity and mortality in patients with diabetic nephropathy
Detailed Description:
Diabetic nephropathy has become the leading cause of end stage renal disease ESRD in the western world accounting for approximately 40 of new cases in the US and up to 20 to 30 in Europe
Current treatments for diabetic nephropathy usually try to deal with the underlying diabetes or they aim to reduce cardiovascular risk factors such as hypertension hyperglycemia smoking and dyslipidemia A few recently approved drugs such as irbesartan and losartan for type 2 diabetic nephropathy have a renoprotective activity beyond their antihypertensive effect However morbidity and mortality rates remain high
Avosentan may have a positive effect on reducing the amount of protein lost in the urine and if this is the case it will help treat patients with diabetic nephropathy
Current treatments for diabetic nephropathy usually try to deal with the underlying diabetes or they aim to reduce cardiovascular risk factors such as hypertension hyperglycemia smoking and dyslipidemia A few recently approved drugs such as irbesartan and losartan for type 2 diabetic nephropathy have a renoprotective activity beyond their antihypertensive effect However morbidity and mortality rates remain high
Avosentan may have a positive effect on reducing the amount of protein lost in the urine and if this is the case it will help treat patients with diabetic nephropathy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-000604-14 | None | None | None |