Renoprotective Effect of Nisoldipine and Lisinopril in Ty... | NCT00311870

Studies
Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

NCT00311870

Sponsor

Steno Diabetes Center Copenhagen

Status

Completed

Last Update Posted

Apr 6, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Diabetic Nephropathy

Interventions

nisoldipine
lisinopril

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 1999

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1993

Primary Completion Date

Not provided

Completion Date

Apr 1999

First Submitted Date

Apr 4, 2006

First Submission Date that Met QC Criteria

Apr 4, 2006

First Posted Date

Apr 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2006

Last Update Posted Date

Apr 6, 2006Estimated

Name	Class
Bayer	INDUSTRY

Description Module

Brief Summary

The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in glomerular filtration rate from study start to study end

Secondary Outcomes

Measure	Description	Time Frame
blood pressure response
change in urinary albumin excretion rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diabetic nephropathy, type 1 diabetes, hypertension

Exclusion Criteria:

child bearing potential, non-diabetic kidney disease, malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Rossing, MD	Steno Diabetes Center Copenhagen	Principal Investigator
Hans-Henrik Parving, MD	Steno Diabetes Center Copenhagen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Steno Diabetes Center		Gentofte Municipality		DK-2820	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11128341	Result	Tarnow L, Rossing P, Jensen C, Hansen BV, Parving HH. Long-term renoprotective effect of nisoldipine and lisinopril in type 1 diabetic patients with diabetic nephropathy. Diabetes Care. 2000 Dec;23(12):1725-30. doi: 10.2337/diacare.23.12.1725.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Name	Type	Description	Arm Group Labels	Other Names
nisoldipine	Drug
lisinopril	Drug