Clincosm LogoSign in Get a demo

Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00300482
Collaborator
(none)
1,445
Enrollment
1
Location
6
Arms

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)

  • rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.
Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1445 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

ABT-335 + 10 mg rosuvastatin

Drug: ABT-335
135 mg, daily, 12 weeks

Drug: Rosuvastatin Calcium
Daily, 12 weeks, see Arm Description for dosage information
Other Names:
  • Rosuvastatin

    		•
    Active Comparator: B

    ABT-335 + 20 mg rosuvastatin

    Drug: ABT-335
    135 mg, daily, 12 weeks

    Drug: Rosuvastatin Calcium
    Daily, 12 weeks, see Arm Description for dosage information
    Other Names:
  • Rosuvastatin

    		•
    Placebo Comparator: C

    ABT-335 monotherapy

    Drug: ABT-335
    135 mg, daily, 12 weeks

    Drug: Placebo
    Daily, 12 weeks, see Arm Description for information regarding placebo type
    Placebo Comparator: D

    10 mg rosuvastatin monotherapy

    Drug: Rosuvastatin Calcium
    Daily, 12 weeks, see Arm Description for dosage information
    Other Names:
  • Rosuvastatin

    • Drug: Placebo
    Daily, 12 weeks, see Arm Description for information regarding placebo type
    Placebo Comparator: E

    20 mg rosuvastatin monotherapy

    Drug: Rosuvastatin Calcium
    Daily, 12 weeks, see Arm Description for dosage information
    Other Names:
  • Rosuvastatin

    • Drug: Placebo
    Daily, 12 weeks, see Arm Description for information regarding placebo type
    Placebo Comparator: F

    40 mg rosuvastatin monotherapy

    Drug: Rosuvastatin Calcium
    Daily, 12 weeks, see Arm Description for dosage information
    Other Names:
  • Rosuvastatin

    • Drug: Placebo
    Daily, 12 weeks, see Arm Description for information regarding placebo type

    Outcome Measures

    Primary Outcome Measures

    1. Mean Percent Change in Triglycerides From Baseline to Final Visit [Baseline to 12 Weeks]

      [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100

    2. Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [Baseline to 12 Weeks]

      [(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100

    3. Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit [Baseline to 12 Weeks]

      [(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100

    Secondary Outcome Measures

    1. Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit [Baseline to 12 Weeks]

      [(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100

    2. Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit [Baseline to 12 Weeks]

      [(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100

    3. Mean Percent Change in Total Cholesterol From Baseline to Final Visit [Baseline to 12 Weeks]

      [(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100

    4. Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit [Baseline to 12 Weeks]

      [(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100

    5. Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit [Baseline to 12 Weeks]

      [(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with mixed dyslipidemia
    Exclusion Criteria:

    • Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.

    • Patients who are taking certain medications or unstable dose of specific medications.

    • Women who are pregnant or plan on becoming pregnant or women who are lactating.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Global Medical Information North Chicago Illinois United States 60064

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Principal Investigator: Maureen Kelly, MD, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00300482
    Other Study ID Numbers:
    • M05-748
    First Posted:
    Mar 9, 2006
    Last Update Posted:
    Jun 10, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    Dyslipidemia
    Coronary Heart Disease
    Mixed Dyslipidemia
    Additional relevant MeSH terms:
    Heart Diseases
    Coronary Disease
    Coronary Artery Disease
    Myocardial Ischemia
    Dyslipidemias
    Rosuvastatin Calcium
    Calcium

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Six subjects were randomized but not treated: 1 was lost to follow-up, 1 was randomized but deemed ineligible, 1 was withdrawn at the investigator's discretion, and 3 withdrew consent.
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    Period Title: Overall Study
    STARTED 261 261 259 261 266 131
    COMPLETED 220 220 208 237 243 115
    NOT COMPLETED 41 41 51 24 23 16

    Baseline Characteristics

    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin Total
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily Total of all reporting groups
    Overall Participants 261 261 259 261 266 131 1439
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    206
    78.9%
    209
    80.1%
    209
    80.7%
    222
    85.1%
    217
    81.6%
    103
    78.6%
    1166
    81%
    >=65 years
    55
    21.1%
    52
    19.9%
    50
    19.3%
    39
    14.9%
    49
    18.4%
    28
    21.4%
    273
    19%
    Sex: Female, Male (Count of Participants)
    Female
    148
    56.7%
    131
    50.2%
    152
    58.7%
    130
    49.8%
    124
    46.6%
    65
    49.6%
    750
    52.1%
    Male
    113
    43.3%
    130
    49.8%
    107
    41.3%
    131
    50.2%
    142
    53.4%
    66
    50.4%
    689
    47.9%
    Region of Enrollment (participants) [Number]
    North America
    261
    100%
    261
    100%
    259
    100%
    261
    100%
    266
    100%
    131
    100%
    1439
    100%

    Outcome Measures

    1. Primary Outcome
    Title Mean Percent Change in Triglycerides From Baseline to Final Visit
    Description [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100
    Time Frame Baseline to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    Measure Participants 252 249 242 252 255 127
    Mean (Standard Error) [percent change]
    -47.1
    (1.81)
    -42.9
    (1.82)
    -32.6
    (1.84)
    -24.4
    (1.81)
    -25.6
    (1.80)
    -32.1
    (2.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-335 + 10 mg Rosuvastatin, 10 mg Rosuvastatin
    Comments An n = 205 per arm would provide >99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ABT-335 + 20 mg Rosuvastatin, 20 mg Rosuvastatin
    Comments An n = 205 per arm would provide >99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
    Method ANCOVA
    Comments
    2. Primary Outcome
    Title Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
    Description [(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100
    Time Frame Baseline to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    Measure Participants 224 225 220 239 236 115
    Mean (Standard Error) [percent change]
    20.3
    (1.36)
    19.0
    (1.35)
    15.0
    (1.37)
    8.5
    (1.32)
    10.3
    (1.32)
    9.3
    (1.85)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-335 + 10 mg Rosuvastatin, 10 mg Rosuvastatin
    Comments An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ABT-335 + 20 mg Rosuvastatin, 20 mg Rosuvastatin
    Comments An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
    Method ANCOVA
    Comments
    3. Primary Outcome
    Title Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
    Description [(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100
    Time Frame Baseline to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    Measure Participants 231 230 223 243 238 120
    Mean (Standard Error) [percent change]
    -37.2
    (1.21)
    -38.8
    (1.21)
    -6.5
    (1.22)
    -38.0
    (1.18)
    -45.0
    (1.19)
    -50.6
    (1.64)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-335 + 10 mg Rosuvastatin, ABT-335
    Comments An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ABT-335 + 20 mg Rosuvastatin, ABT-335
    Comments An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
    Method ANCOVA
    Comments
    4. Secondary Outcome
    Title Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit
    Description [(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100
    Time Frame Baseline to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    Measure Participants 224 225 220 238 236 115
    Mean (Standard Error) [percent change]
    -44.7
    (1.05)
    -45.3
    (1.04)
    -18.5
    (1.06)
    -39.8
    (1.02)
    -45.8
    (1.02)
    -51.5
    (1.43)
    5. Secondary Outcome
    Title Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
    Description [(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100
    Time Frame Baseline to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    Measure Participants 243 237 235 244 243 126
    Mean (Standard Error) [percent change]
    -55.8
    (3.08)
    -50.6
    (3.10)
    -31.9
    (3.13)
    -41.0
    (3.07)
    -42.1
    (3.07)
    -49.1
    (4.17)
    6. Secondary Outcome
    Title Mean Percent Change in Total Cholesterol From Baseline to Final Visit
    Description [(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100
    Time Frame Baseline to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    Measure Participants 252 249 242 252 255 127
    Mean (Standard Error) [percent change]
    -34.4
    (0.82)
    -35.7
    (0.83)
    -13.5
    (0.84)
    -32.5
    (0.82)
    -37.3
    (0.82)
    -42.7
    (1.13)
    7. Secondary Outcome
    Title Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
    Description [(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100
    Time Frame Baseline to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects with a baseline ApoB and at least 1 postbaseline ApoB value, LOCF
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    Measure Participants 252 244 239 248 252 123
    Mean (Standard Error) [percent change]
    -39.2
    (1.04)
    -39.2
    (1.05)
    -16.2
    (1.06)
    -34.1
    (1.04)
    -39.6
    (1.03)
    -45.0
    (1.45)
    8. Secondary Outcome
    Title Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
    Description [(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100
    Time Frame Baseline to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    Measure Participants 252 246 241 249 254 125
    Median (Inter-Quartile Range) [percent change]
    -33.8
    (16.87)
    -40.8
    (17.01)
    -12.1
    (17.20)
    -22.9
    (16.92)
    -29.9
    (16.78)
    -33.1
    (23.31)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Arm/Group Description ABT-335 + 10 mg rosuvastatin combination therapy once daily ABT-335 + 20 mg rosuvastatin combination therapy once daily ABT-335 monotherapy once daily 10 mg rosuvastatin monotherapy once daily 20 mg rosuvastatin monotherapy once daily 40 mg rosuvastatin monotherapy once daily
    All Cause Mortality
    ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/ (NaN) 3/ (NaN) 10/ (NaN) 3/ (NaN) 7/ (NaN) 2/ (NaN)
    Cardiac disorders
    Coronary artery disease 1/261 (0.4%) 1/261 (0.4%) 1/259 (0.4%) 0/261 (0%) 1/266 (0.4%) 0/131 (0%)
    Myocardial infarction 2/261 (0.8%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Myocardial ischaemia 0/261 (0%) 1/261 (0.4%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Pericarditis 1/261 (0.4%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Gastrointestinal disorders
    Colitis 0/261 (0%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 1/266 (0.4%) 0/131 (0%)
    Gastroesophageal reflux disease 0/261 (0%) 0/261 (0%) 0/259 (0%) 1/261 (0.4%) 0/266 (0%) 0/131 (0%)
    Pancreatitis acute 1/261 (0.4%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Diverticulitis 0/261 (0%) 1/261 (0.4%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    General disorders
    Chest pain 1/261 (0.4%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Non-cardiac chest pain 0/261 (0%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Infections and infestations
    Bronchitis 0/261 (0%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Gastroenteritis 1/261 (0.4%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Kidney infection 0/261 (0%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Pneumonia 1/261 (0.4%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Pyothorax 0/261 (0%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Sepsis 0/261 (0%) 0/261 (0%) 0/259 (0%) 1/261 (0.4%) 0/266 (0%) 0/131 (0%)
    Septic shock 0/261 (0%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Urinary tract infection 0/261 (0%) 0/261 (0%) 0/259 (0%) 1/261 (0.4%) 0/266 (0%) 0/131 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/261 (0%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 1/266 (0.4%) 0/131 (0%)
    Osteonecrosis 1/261 (0.4%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Rheumatoid arthritis 1/261 (0.4%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 0/261 (0%) 0/261 (0%) 2/259 (0.8%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Prostate cancer 0/261 (0%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 1/266 (0.4%) 0/131 (0%)
    Nervous system disorders
    Guillain-Barre syndrome 0/261 (0%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 1/266 (0.4%) 0/131 (0%)
    Presyncope 0/261 (0%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 1/266 (0.4%) 0/131 (0%)
    Syncope 1/261 (0.4%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Renal and urinary disorders
    Nephrolithiasis 0/261 (0%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 1/266 (0.4%) 0/131 (0%)
    Renal failure 0/261 (0%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Renal pain 0/261 (0%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Reproductive system and breast disorders
    Vaginal prolapse 0/261 (0%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 1/131 (0.8%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/261 (0%) 0/261 (0%) 0/259 (0%) 1/261 (0.4%) 0/266 (0%) 0/131 (0%)
    Asthma 1/261 (0.4%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Dyspnea 1/261 (0.4%) 0/261 (0%) 0/259 (0%) 0/261 (0%) 0/266 (0%) 0/131 (0%)
    Vascular disorders
    Peripheral vascular disorder 0/261 (0%) 0/261 (0%) 1/259 (0.4%) 0/261 (0%) 0/266 (0%) 1/131 (0.8%)
    Other (Not Including Serious) Adverse Events
    ABT-335 + 10 mg Rosuvastatin ABT-335 + 20 mg Rosuvastatin ABT-335 10 mg Rosuvastatin 20 mg Rosuvastatin 40 mg Rosuvastatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 126/ (NaN) 114/ (NaN) 117/ (NaN) 109/ (NaN) 110/ (NaN) 61/ (NaN)
    Gastrointestinal disorders
    Constipation 11/261 (4.2%) 7/261 (2.7%) 9/259 (3.5%) 6/261 (2.3%) 9/266 (3.4%) 4/131 (3.1%)
    Diarrhea 7/261 (2.7%) 8/261 (3.1%) 7/259 (2.7%) 6/261 (2.3%) 8/266 (3%) 6/131 (4.6%)
    Dyspepsia 5/261 (1.9%) 13/261 (5%) 9/259 (3.5%) 9/261 (3.4%) 7/266 (2.6%) 5/131 (3.8%)
    Nausea 9/261 (3.4%) 14/261 (5.4%) 12/259 (4.6%) 12/261 (4.6%) 11/266 (4.1%) 5/131 (3.8%)
    Stomach discomfort 3/261 (1.1%) 2/261 (0.8%) 3/259 (1.2%) 5/261 (1.9%) 3/266 (1.1%) 5/131 (3.8%)
    General disorders
    Fatigue 12/261 (4.6%) 12/261 (4.6%) 6/259 (2.3%) 7/261 (2.7%) 7/266 (2.6%) 4/131 (3.1%)
    Pain 7/261 (2.7%) 2/261 (0.8%) 8/259 (3.1%) 7/261 (2.7%) 2/266 (0.8%) 6/131 (4.6%)
    Infections and infestations
    Nasopharyngitis 10/261 (3.8%) 9/261 (3.4%) 6/259 (2.3%) 14/261 (5.4%) 8/266 (3%) 5/131 (3.8%)
    Sinusitis 9/261 (3.4%) 6/261 (2.3%) 10/259 (3.9%) 2/261 (0.8%) 3/266 (1.1%) 3/131 (2.3%)
    Upper respiratiory tract infection 12/261 (4.6%) 12/261 (4.6%) 10/259 (3.9%) 5/261 (1.9%) 6/266 (2.3%) 4/131 (3.1%)
    Investigations
    Alanine aminotransferase increased 4/261 (1.5%) 9/261 (3.4%) 4/259 (1.5%) 2/261 (0.8%) 2/266 (0.8%) 2/131 (1.5%)
    Aspartate aminotransferase increased 4/261 (1.5%) 8/261 (3.1%) 3/259 (1.2%) 2/261 (0.8%) 1/266 (0.4%) 2/131 (1.5%)
    Blood creatine phosphokinase increased 5/261 (1.9%) 5/261 (1.9%) 4/259 (1.5%) 3/261 (1.1%) 7/266 (2.6%) 4/131 (3.1%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 11/261 (4.2%) 8/261 (3.1%) 10/259 (3.9%) 10/261 (3.8%) 9/266 (3.4%) 9/131 (6.9%)
    Back pain 15/261 (5.7%) 15/261 (5.7%) 17/259 (6.6%) 17/261 (6.5%) 16/266 (6%) 6/131 (4.6%)
    Muscle spasms 7/261 (2.7%) 6/261 (2.3%) 3/259 (1.2%) 10/261 (3.8%) 12/266 (4.5%) 4/131 (3.1%)
    Myalgia 10/261 (3.8%) 7/261 (2.7%) 7/259 (2.7%) 15/261 (5.7%) 9/266 (3.4%) 9/131 (6.9%)
    Osteoarthritis 0/261 (0%) 2/261 (0.8%) 3/259 (1.2%) 1/261 (0.4%) 0/266 (0%) 4/131 (3.1%)
    Pain in extremity 5/261 (1.9%) 8/261 (3.1%) 14/259 (5.4%) 14/261 (5.4%) 9/266 (3.4%) 6/131 (4.6%)
    Nervous system disorders
    Dizziness 12/261 (4.6%) 9/261 (3.4%) 12/259 (4.6%) 4/261 (1.5%) 6/266 (2.3%) 0/131 (0%)
    Headache 40/261 (15.3%) 23/261 (8.8%) 30/259 (11.6%) 33/261 (12.6%) 44/266 (16.5%) 20/131 (15.3%)
    Psychiatric disorders
    Insomnia 6/261 (2.3%) 8/261 (3.1%) 6/259 (2.3%) 3/261 (1.1%) 3/266 (1.1%) 3/131 (2.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 6/261 (2.3%) 4/261 (1.5%) 6/259 (2.3%) 3/261 (1.1%) 1/266 (0.4%) 4/131 (3.1%)
    Pharyngolaryngeal pain 3/261 (1.1%) 2/261 (0.8%) 3/259 (1.2%) 7/261 (2.7%) 3/266 (1.1%) 4/131 (3.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Not to publish or present the results before the publication of the multi-center investigator paper, but in no event shall be so restricted after the expiration of twelve (12) months from completion of the studies at all sites. Any presentation or publication to be submitted to Sponsor (in draft of the same) for Sponsor review and comment.

    Results Point of Contact

    Name/Title Medical Information Specialist
    Organization Abbott
    Phone 800-633-9110
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00300482
    Other Study ID Numbers:
    • M05-748
    First Posted:
    Mar 9, 2006
    Last Update Posted:
    Jun 10, 2009
    Last Verified:
    Jun 1, 2009