Trials Sponsors Conditions Drugs Pricing

Conditions

Dyslipidemia Kidney Disease

Keywords

DyslipidemiaKidney Disease

Outcome Measures

Primary Outcomes (1)

Median Percent Change in Triglycerides From Baseline to Week 8.
Triglycerides were measured in milligrams/deciliter.
Baseline to 8 weeks

Secondary Outcomes (1)

Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.
Baseline to 8 weeks

Study Arms (2)

ABT-335 plus rosuvastatin

EXPERIMENTAL

ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks

Drug: ABT-335 plus rosuvastatin

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks

Drug: Rosuvastatin

Interventions

ABT-335 plus rosuvastatinDrug

ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks

Also known as: fenofibric acid and rosuvastatin

ABT-335 plus rosuvastatin

RosuvastatinDrug

Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks

Also known as:

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment programme
ABT-335 plus rosuvastatin
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Dyslipidemic participants with Chronic Kidney Disease Stage 3
For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit\[s\]):

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (114)

Site Reference ID/Investigator# 22521

Birmingham, Alabama, 35242, United States

Site Reference ID/Investigator# 22478

Huntsville, Alabama, 35801, United States

Site Reference ID/Investigator# 8365

Madison, Alabama, 35758, United States

Site Reference ID/Investigator# 8416

Montgomery, Alabama, 36106-1111, United States

Site Reference ID/Investigator# 7869

Chula Vista, California, 91910, United States

Site Reference ID/Investigator# 8435

Fountain Valley, California, 92708, United States

Site Reference ID/Investigator# 22487

Related Publications (2)

Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
PMID: 38018702DERIVED
Weinstein DL, Williams LA, Carlson DM, Kelly MT, Burns KM, Setze CM, Lele A, Stolzenbach JC. A randomized, double-blind study of fenofibric acid plus rosuvastatin compared with rosuvastatin alone in stage 3 chronic kidney disease. Clin Ther. 2013 Aug;35(8):1186-98. doi: 10.1016/j.clinthera.2013.06.013. Epub 2013 Jul 26.
PMID: 23891363DERIVED

MeSH Terms

Conditions

DyslipidemiasKidney Diseases

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acidRosuvastatin Calciumfenofibric acid

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title: Gerard Lynch
Organization: AstraZeneca

Study Officials

Torbjörn Lundström, MD
AstraZeneca
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

280 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

June 2008

Date type not reported

This date has not been verified as actual or estimated.

30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

ABT-335 plus rosuvastatin

Rosuvastatin

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (114)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

ABT-335 plus rosuvastatin

Rosuvastatin

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (114)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations