Trial to Evaluate the Efficacy of Fluvastatin on Certain... | NCT00171262

Studies
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

NCT00171262

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

120Actual

Phase

Phase 4

Conditions

Dyslipidemia

Interventions

Fluvastatin

Countries

Spain

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 2017

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

Aug 2004

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 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 20, 2017

Last Update Posted Date

Feb 23, 2017Actual

Description Module

Brief Summary

To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing certain inflammatory markers. In addition, tolerability and safety will also be evaluated in a Spanish population.

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

120Actual

Name	Type	Description	Arm Group Labels	Other Names
Fluvastatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in serum inflammatory markers after 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in fibrosis parameters and endothelial function after 52 weeks
Adverse events and serious adverse events after 52 weeks
Change from baseline in laboratory tests of kidney function after 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients > 18 years Patients that give their inform consent

Exclusion Criteria:

Pregnant women Diabetic patients Treated with statins for the year prior to study inclusion Patients with contraindications listed in fluvastatin prescribing information

Other protocol-defined in and exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 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
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis		Madrid			Spain

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D051437	Renal Insufficiency

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077340	Fluvastatin

Ancestor Terms

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided