Trial Outcomes & Findings for Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. (NCT NCT00300430)
NCT ID: NCT00300430
Last Updated: 2009-07-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1911 participants
Primary outcome timeframe
Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy
Results posted on
2009-07-23
Participant Flow
1895 subjects were treated in this study. 306 others who did not enroll in this study but were treated with combo therapy in preceding double-blind studies are included in analyses of adverse events. Six subjects were enrolled, but never received study drug. An additional 10 subjects from a site that was closed were not included in any analysis.
Participant milestones
| Measure |
ABT-335 + 20 mg Rosuvastatin
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
1186
|
514
|
501
|
|
Overall Study
COMPLETED
|
819
|
345
|
350
|
|
Overall Study
NOT COMPLETED
|
367
|
169
|
151
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
Baseline characteristics by cohort
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=1186 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=514 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=501 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
Total
n=2201 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
965 Participants
n=5 Participants
|
440 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
1802 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
221 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
398 Participants
n=4 Participants
|
|
Age Continuous
|
55.1 years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 10.25 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 10.69 • n=4 Participants
|
|
Sex: Female, Male
Female
|
608 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
1120 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
578 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
1081 Participants
n=4 Participants
|
|
Region of Enrollment
North America
|
1186 participants
n=5 Participants
|
514 participants
n=7 Participants
|
501 participants
n=5 Participants
|
2201 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapyPopulation: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or in this open-label study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=1186 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=514 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=501 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
|
83 percentage of participants
|
86 percentage of participants
|
85 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52 of the open-label studyPopulation: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=284 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=120 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=122 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study
|
-53.0 percent change
Full Range 27.67 • Interval -92.7 to 87.9
|
-47.7 percent change
Full Range 24.62 • Interval -89.7 to 74.8
|
-56.2 percent change
Full Range 24.56 • Interval -92.5 to 60.7
|
SECONDARY outcome
Timeframe: Baseline to Week 52 of the open-label studyPopulation: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=284 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=120 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=121 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study
|
25.2 percent change
Standard Deviation 23.22
|
25.1 percent change
Standard Deviation 25.08
|
19.4 percent change
Standard Deviation 20.58
|
SECONDARY outcome
Timeframe: Baseline to Week 52 of the open-label studyPopulation: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=283 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=120 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=121 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study
|
-41.6 percent change
Standard Deviation 20.77
|
-30.2 percent change
Standard Deviation 21.83
|
-38.1 percent change
Standard Deviation 19.09
|
SECONDARY outcome
Timeframe: Baseline to Week 52 in this open-label studyPopulation: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=284 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=120 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=121 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study
|
-48.8 percent change
Standard Deviation 15.80
|
-36.6 percent change
Standard Deviation 16.90
|
-44.3 percent change
Standard Deviation 15.72
|
SECONDARY outcome
Timeframe: Baseline to Week 52 of the open-label studyPopulation: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=272 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=117 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=122 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study
|
-56.9 percent change
Standard Deviation 27.85
|
-37.7 percent change
Standard Deviation 63.12
|
-52.2 percent change
Standard Deviation 36.54
|
SECONDARY outcome
Timeframe: Baseline to Week 52 of the open-label studyPopulation: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=284 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=120 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=122 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study
|
-37.9 percent change
Standard Deviation 13.14
|
-27.5 percent change
Standard Deviation 14.60
|
-35.0 percent change
Standard Deviation 13.01
|
SECONDARY outcome
Timeframe: Baseline to Week 52 of the open-label studyPopulation: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=277 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=115 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=120 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study
|
-44.8 percent change
Standard Deviation 15.40
|
-35.5 percent change
Standard Deviation 14.85
|
-42.9 percent change
Standard Deviation 14.23
|
SECONDARY outcome
Timeframe: Baseline to Week 52 of the open-label studyPopulation: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=279 Participants
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
n=117 Participants
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
n=120 Participants
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study
|
-38.87 percent change
Full Range 265.37 • Interval -94.5 to 1166.0
|
-27.72 percent change
Full Range 93.62 • Interval -99.8 to 2558.5
|
-39.13 percent change
Full Range 70.99 • Interval -95.4 to 384.3
|
Adverse Events
ABT-335 + 20 mg Rosuvastatin
Serious events: 85 serious events
Other events: 646 other events
Deaths: 0 deaths
ABT-335 + 40 mg Simvastatin
Serious events: 40 serious events
Other events: 308 other events
Deaths: 0 deaths
ABT-335 + 40 mg Atorvastatin
Serious events: 23 serious events
Other events: 283 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-335 + 20 mg Rosuvastatin
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Cardiac disorders
Acute myocardial infarction
|
0.08%
1/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Cardiac disorders
Angina pectoris
|
0.08%
1/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Cardiac disorders
Atrial flutter
|
0.17%
2/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Cardiac disorders
Cardiac failure congestive
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Cardiac disorders
Coronary artery disease
|
0.42%
5/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Cardiac disorders
Myocardial infarction
|
0.34%
4/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Cardiac disorders
Myocardial ischemia
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Cardiac disorders
Pericarditis
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Eye disorders
Vitreous detachment
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Duodenitis
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Dysphagia
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Enterocele
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Gastrointestinal disorders
Pancreatitis
|
0.08%
1/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1186
|
0.39%
2/514
|
0.00%
0/501
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
General disorders
Chest discomfort
|
0.08%
1/1186
|
0.00%
0/514
|
0.40%
2/501
|
|
General disorders
Chest pain
|
0.17%
2/1186
|
0.19%
1/514
|
0.40%
2/501
|
|
General disorders
Non-cardiac chest pain
|
0.08%
1/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
2/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.17%
2/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1186
|
0.19%
1/514
|
0.20%
1/501
|
|
Immune system disorders
Latex allergy
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Infections and infestations
Abdominal wall infection
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Infections and infestations
Bacteremia
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Infections and infestations
Cellulitis
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Infections and infestations
Diverticulitis
|
0.34%
4/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Infections and infestations
Gastroenteritis
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Infections and infestations
Gastroenteritis viral
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Infections and infestations
Orchitis
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Infections and infestations
Postoperative wound infection
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Infections and infestations
Subcutaneous abscess
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Infections and infestations
Upper respiratory tract infection
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Infections and infestations
Urinary tract infection
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.08%
1/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Injury, poisoning and procedural complications
Post procedural hematoma
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Injury, poisoning and procedural complications
Post procedural sepsis
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Investigations
Blood pressure increased
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Investigations
Ultrasound kidney abnormal
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Metabolism and nutrition disorders
Obesity
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.08%
1/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.25%
3/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.51%
6/1186
|
0.78%
4/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumor
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
1/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumor benign
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Nervous system disorders
Brain edema
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Nervous system disorders
Brain stem infarction
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1186
|
0.19%
1/514
|
0.20%
1/501
|
|
Nervous system disorders
Dementia
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Nervous system disorders
Headache
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Nervous system disorders
Lethargy
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Nervous system disorders
Migraine
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Nervous system disorders
Presyncope
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Nervous system disorders
Somnolence
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Nervous system disorders
Syncope
|
0.17%
2/1186
|
0.19%
1/514
|
0.20%
1/501
|
|
Nervous system disorders
Transient ischemic attack
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.08%
1/1186
|
0.19%
1/514
|
0.20%
1/501
|
|
Psychiatric disorders
Anxiety disorder
|
0.08%
1/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Psychiatric disorders
Confusional state
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Psychiatric disorders
Major depression
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Psychiatric disorders
Mental status changes
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Renal and urinary disorders
Calculus ureteric
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Renal and urinary disorders
Glomerulonephritis proliferative
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Renal and urinary disorders
Hematuria
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Renal and urinary disorders
Renal colic
|
0.08%
1/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Reproductive system and breast disorders
Cystocele
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Reproductive system and breast disorders
Rectocele
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Reproductive system and breast disorders
Uterine pain
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.17%
2/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.17%
2/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
2/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/1186
|
0.19%
1/514
|
0.00%
0/501
|
|
Vascular disorders
Deep vein thrombosis
|
0.34%
4/1186
|
0.19%
1/514
|
0.20%
1/501
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Vascular disorders
Hypotension
|
0.08%
1/1186
|
0.00%
0/514
|
0.20%
1/501
|
|
Vascular disorders
Intermittent claudication
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.08%
1/1186
|
0.00%
0/514
|
0.00%
0/501
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1186
|
0.00%
0/514
|
0.20%
1/501
|
Other adverse events
| Measure |
ABT-335 + 20 mg Rosuvastatin
ABT-335 and 20 mg rosuvastatin combination therapy
|
ABT-335 + 40 mg Simvastatin
ABT-335 and 40 mg simvastatin combination therapy
|
ABT-335 + 40 mg Atorvastatin
ABT-335 and 40 mg atorvastatin combination therapy
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.1%
49/1186
|
5.1%
26/514
|
6.6%
33/501
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
42/1186
|
6.0%
31/514
|
5.6%
28/501
|
|
Gastrointestinal disorders
Nausea
|
5.1%
61/1186
|
4.5%
23/514
|
6.8%
34/501
|
|
Infections and infestations
Bronchitis
|
5.1%
60/1186
|
4.9%
25/514
|
4.6%
23/501
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
116/1186
|
13.6%
70/514
|
11.6%
58/501
|
|
Infections and infestations
Sinusitis
|
7.7%
91/1186
|
7.8%
40/514
|
7.4%
37/501
|
|
Infections and infestations
Upper respiratory tract infection
|
12.2%
145/1186
|
13.4%
69/514
|
11.4%
57/501
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
86/1186
|
10.5%
54/514
|
7.6%
38/501
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
118/1186
|
10.9%
56/514
|
8.4%
42/501
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.6%
55/1186
|
6.6%
34/514
|
7.0%
35/501
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
60/1186
|
5.3%
27/514
|
5.0%
25/501
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
53/1186
|
6.2%
32/514
|
6.6%
33/501
|
|
Nervous system disorders
Headache
|
13.5%
160/1186
|
14.6%
75/514
|
14.8%
74/501
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
49/1186
|
6.8%
35/514
|
6.4%
32/501
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
23/1186
|
5.1%
26/514
|
4.2%
21/501
|
Additional Information
Medical Information Specialist
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER