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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

Information source: Abbott
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemias; Coronary Heart Disease; Kidney Disease

Intervention: ABT-335 (Drug); Rosuvastatin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Abbott

Overall contact:
Debra Schuerr, Phone: (847) 937-5748, Email: debra.m.schuerr@abbott.com

Summary

The objective of this study is to evaluate the safety and effectiveness of the combination of rosuvastatin and ABT-335 in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rate of change of triglycerides

Secondary outcome: Rate of change of HDL-C

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Dyslipidemic subjects with Chronic Kidney Disease Stage 3

Exclusion Criteria:

- Patients with certain chronic or unstable medical conditions.

- Patients with unstable dose of medications or receiving Coumadin, cyclosporine, or

certain other medications.

- Pregnant or lactating women, or women intending to become pregnant.

- Patient with diabetes mellitus that is poorly controlled.

Locations and Contacts

Debra Schuerr, Phone: (847) 937-5748, Email: debra.m.schuerr@abbott.com

Carolina 00983, Puerto Rico; Recruiting
Rodriguez-Vigil

Carrion Manati 00675, Puerto Rico; Recruiting
Ortiz-Carrasquillo

Humacao 00791, Puerto Rico; Recruiting
Rios

Ponce 00717, Puerto Rico; Recruiting
Vazquez-Tanus

Ponce 00717, Puerto Rico; Recruiting
Vazquez-Roura

Rio Piedras 00935, Puerto Rico; Recruiting
Burgos-Calderone

San Juan 00909, Puerto Rico; Completed

San Juan 00918, Puerto Rico; Recruiting
Cangiano

San Juan 00907, Puerto Rico; Completed

Toa Baja 00949, Puerto Rico; Recruiting
Comulada-Rivera

Yabucoa 00767, Puerto Rico; Recruiting
Vergara

Birmingham, Alabama 35242, United States; Recruiting
Rock

Huntsville, Alabama 35801, United States; Recruiting
Carter

Madison, Alabama 35758, United States; Completed

Montgomery, Alabama 36106-1111, United States; Withdrawn

Hot Springs, Arkansas 71901, United States; Recruiting
McCrary, Jr.

Chula Vista, California 91910, United States; Recruiting
Belo

Fountain Valley, California 92708, United States; Terminated

Glendale, California 91204, United States; Completed

La Mesa, California 91942, United States; Withdrawn

Long Beach, California 90806, United States; Recruiting
Cheung

Los Angeles, California 90073, United States; Completed

Los Angeles, California 90048, United States; Completed

Norwalk, California 90650, United States; Recruiting
Cruz

Riverside, California 92505, United States; Recruiting
Sun

Roseville, California 95661, United States; Recruiting
Wayne

Sacramento, California 95825, United States; Recruiting
Sockolov

San Diego, California 92123, United States; Withdrawn

Simi Valley, California 93065, United States; Recruiting
Yan

West Hills, California 91307, United States; Recruiting
White, S

Lakewood, Colorado, United States; Completed

Lakewood, Colorado 80214, United States; Recruiting

Thorton, Colorado 80260, United States; Recruiting
Gillum

Westminster, Colorado 80031, United States; Recruiting
Anger

Boynton Beach, Florida 33472, United States; Recruiting
Weinstein

Clearwater, Florida 33756, United States; Completed

Coral Springs, Florida 33065, United States; Recruiting
Perwien

Daytona Beach, Florida 32117, United States; Recruiting
Blair-Britt

Gainesville, Florida 32610-0224, United States; Completed

Hollywood, Florida 33021, United States; Recruiting
Lerman

Hudson, Florida 34667, United States; Recruiting
Acharya

Kissimmee, Florida 34741, United States; Recruiting
Link

Lauderdale Lakes, Florida 33313, United States; Recruiting
Echeverri

Longwood, Florida 32779, United States; Recruiting
Tamayo

New Port Richey, Florida 34652, United States; Recruiting
Plevin

Orlando, Florida 32804, United States; Completed

Ormond Beach, Florida 32714, United States; Recruiting
Torres

Pembroke Pines, Florida 33028, United States; Recruiting
Zeig

Plant City, Florida 33563, United States; Recruiting
Gimness

Port Charlotte, Florida 33952, United States; Recruiting
Kaveh

Tampa, Florida 33607, United States; Recruiting
Rangel

Vero Beach, Florida 32960, United States; Recruiting
Moore

West Palm Beach, Florida 33401, United States; Recruiting
Kaye

Winter Haven, Florida 33880, United States; Recruiting
Miller, C

Atlanta, Georgia 30331, United States; Recruiting
Cleveland

Dunwoody, Georgia 30338, United States; Recruiting
Miller

Macon, Georgia 31217, United States; Recruiting
Martinez

Marietta, Georgia 30060, United States; Withdrawn

Roswell, Georgia 30076, United States; Recruiting
Reed

Suwanee, Georgia 30024, United States; Recruiting
Herman

Aurora, Illinois 60504, United States; Withdrawn

Chicago, Illinois 60616, United States; Recruiting
Levinson

Peoria, Illinois 61603, United States; Recruiting
Bland

Mishawaka, Indiana 46544, United States; Recruiting
Asgaonkar

Council Bluffs, Iowa 51505, United States; Recruiting
Marar

Iowa City, Iowa 52242, United States; Recruiting
Robinson

Paducah, Kentucky 42003, United States; Withdrawn

New Orleans, Louisiana 70121, United States; Recruiting
Husserl

Shreveport, Louisiana 71101, United States; Recruiting
Noble

Auburn, Maine 04210, United States; Recruiting
Weiss

Bel Air, Maryland 21015, United States; Withdrawn

Pikesville, Maryland 21208, United States; Terminated

Rockville, Maryland 20852, United States; Recruiting
Belledonne

Fall River, Massachusetts 02720, United States; Recruiting
Zuniga

Springfield, Massachusetts 01107, United States; Withdrawn

Springfield, Massachusetts 01107, United States; Recruiting
Germain

Royal Oak, Michigan 48073, United States; Recruiting
McCullough, P.

Brooklyn Center, Minnesota 55430, United States; Recruiting
Lunde

Olive Branch, Mississippi 38654, United States; Recruiting
Huling

Berlin, New Jersey 08009, United States; Recruiting
Hassman

Elizabeth, New Jersey 07202, United States; Recruiting
Oberoi

Hillsborough, New Jersey 08844, United States; Recruiting
Allegar

Flushing, New York 11355, United States; Recruiting
Spinowitz

Great Neck, New York 11021-5501, United States; Withdrawn

Lake Success, New York 11042, United States; Withdrawn

Williamsville, New York 14221, United States; Recruiting
Kozinn

Charlotte, North Carolina 28208, United States; Withdrawn

Charlotte, North Carolina 28626, United States; Recruiting
Howard, J.

Charlotte, North Carolina 28277, United States; Recruiting
Sensenbrenner

Monroe, North Carolina 28112, United States; Withdrawn

Morehead City, North Carolina 28557, United States; Recruiting
Lucas

Cincinnati, Ohio 45267, United States; Recruiting
Kant

Columbus, Ohio 43215-4354, United States; Withdrawn

Mason, Ohio 45040, United States; Recruiting
Weisbrot

Oklahoma City, Oklahoma 73103, United States; Recruiting
Corder

Oklahoma City, Oklahoma, United States; Recruiting
Barreto

Tulsa, Oklahoma 74136, United States; Recruiting
Marple

Bend, Oregon 97701-6051, United States; Terminated

Medford, Oregon 97504, United States; Recruiting
Kerwin

Portland, Oregon 97210, United States; Recruiting
Smiley

Allentown, Pennsylvania 18103, United States; Recruiting
Kopyt

Carlisle, Pennsylvania 17015, United States; Completed

Duncansville, Pennsylvania 16635, United States; Recruiting
Kivitz

Jersey Shore, Pennsylvania 17740, United States; Recruiting
Patel, R.

Johnstown, Pennsylvania 15904, United States; Completed

Mansfield, Pennsylvania 16933, United States; Completed

Perkasie, Pennsylvania 18944, United States; Recruiting
Moll

Philadelphia, Pennsylvania 19141, United States; Withdrawn

Philadelphia, Pennsylvania 19107, United States; Completed

Tipton, Pennsylvania 16684, United States; Recruiting
Levinson

Warminster, Pennsylvania 18974, United States; Recruiting
Topkis

Providence, Rhode Island 02904, United States; Recruiting
Cottiero

Charleston, South Carolina 29412, United States; Recruiting
Durrence

Columbia, South Carolina 29209, United States; Recruiting
Goldstein

Greenville, South Carolina 29605, United States; Recruiting
Patel

Mount Pleasant, South Carolina 29464, United States; Recruiting
Mills

Summerville, South Carolina 29485, United States; Recruiting
Bolster

Murfreesboro, Tennessee 37130, United States; Recruiting
Agarwal

Nashville, Tennessee 37205, United States; Withdrawn

Dallas, Texas 75251, United States; Recruiting
Canadas-Zizzias

Edinburg, Texas 78539, United States; Completed

Fort Worth, Texas 76104, United States; Recruiting
Alvarado

Grand Prairie, Texas 75050, United States; Recruiting
Leach

Houston, Texas 77005, United States; Recruiting
Nolasco

Houston, Texas 77030, United States; Recruiting
Septimus

Houston, Texas 77024, United States; Recruiting
Doshi

Houston, Texas 77074, United States; Completed

Lubbock, Texas 79410, United States; Completed

San Antonio, Texas 78207, United States; Recruiting
Abboud

San Antonio, Texas 78224, United States; Recruiting
Raul Gaona, Sr.

Ogden, Utah 84403, United States; Recruiting
Wahlen

Salt Lake City, Utah 84124, United States; Recruiting
Muse

Gig Harbor, Washington 98335, United States; Withdrawn

Tacoma, Washington 98405, United States; Withdrawn

Vancouver, Washington 98665, United States; Withdrawn

Additional Information

Starting date: July 2008
Last updated: July 2, 2010

Page last updated: October 04, 2010

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