Anti-Proteinuric Response to ACEI, ARB and Diuretics Comb... | NCT00200694

Studies
Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.

NCT00200694

Sponsor

Nantes University Hospital

Status

Terminated

Last Update Posted

Feb 4, 2009Estimated

Enrollment

Phase

Phase 4

Conditions

Heavy Proteinuria

Interventions

ramipril 5 mg + valsartan 80 mg/day,
ramipril 10 mg + valsartan 160 mg/day,
ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.

Countries

France

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulty in patients's inclusion

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

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

Feb 3, 2009

Last Update Posted Date

Feb 4, 2009Estimated

Description Module

Brief Summary

Determine the best strategy for proteinuria lowering in patients with proteinuria > 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.

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

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ramipril 5 mg + valsartan 80 mg/day,	Drug
ramipril 10 mg + valsartan 160 mg/day,	Drug
ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

proteinuria > 1 g/day with ramipril 5 + valsartan 80 mg/day for 2 months
proteinuria changes < 50% on 3 separate dosages over 2 months.

Exclusion criteria:

age < 18 or > 80 years systolic BP < 110 or ≥ 140 mmHg, serum creatinine > 250 mmole/L
serum creatinine increase on ramipril + valsartan > 20%
intolerance to ACEI or ARB

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent LM Esnault, MD PHD	Nantes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nantes		Nantes			France

Condition Browse Module

MeSH Terms

ID	Term
D011507	Proteinuria
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017257	Ramipril
D000068756	Valsartan

Ancestor Terms

ID	Term
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D013777	Tetrazoles

Browse Leaves

Not provided

Browse Branches

Not provided