Trial Outcomes & Findings for A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia (NCT NCT00463606)

NCT ID: NCT00463606

Last Updated: 2012-10-03

Results Overview

The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 760 participants
• Primary outcome timeframe: Baseline to 12 Weeks
• Results posted on: 2012-10-03

Participant Flow

760 participants were randomized at 144 sites in the United States, and 758 participants were treated between 07 June 2007 and 10 February 2008. Two participants were randomized but not treated: 1 was lost to follow-up and 1 was withdrawn at the investigator's discretion.

A total of 168 study sites screened participants, wtih 144 of these sites randomizing participants.

Participant milestones

Measure	ABT-335 and Rosuvastatin Calcium ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	ABT-335 ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks	Rosuvastatin Calcium Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Overall Study STARTED	253	254	251
Overall Study COMPLETED	212	220	231
Overall Study NOT COMPLETED	41	34	20

Reasons for withdrawal

Measure	ABT-335 and Rosuvastatin Calcium ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	ABT-335 ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks	Rosuvastatin Calcium Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Overall Study Adverse Event	21	18	11
Overall Study Withdrawal by Subject	11	11	5
Overall Study Lost to Follow-up	2	2	3
Overall Study Subject noncompliance	1	1	0
Overall Study Subject moved out of town	1	0	0
Overall Study Physician Decision	0	1	0
Overall Study Sponsor request	0	1	0
Overall Study Exclusion criteria violation	2	0	0
Overall Study Coordinator error	1	0	0
Overall Study Patient randomized in error	1	0	0
Overall Study Participation in another ABT-335 trial	1	0	0
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

Baseline characteristics by cohort

Measure	ABT-335 and Rosuvastatin Calcium n=253 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	ABT-335 n=254 Participants ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=251 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks	Total n=758 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	194 Participants n=5 Participants	203 Participants n=7 Participants	205 Participants n=5 Participants	602 Participants n=4 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants	51 Participants n=7 Participants	46 Participants n=5 Participants	156 Participants n=4 Participants
Age Continuous	56.2 years STANDARD_DEVIATION 11.30 • n=5 Participants	54.4 years STANDARD_DEVIATION 11.24 • n=7 Participants	55.3 years STANDARD_DEVIATION 10.71 • n=5 Participants	55.3 years STANDARD_DEVIATION 11.10 • n=4 Participants
Sex: Female, Male Female	161 Participants n=5 Participants	144 Participants n=7 Participants	150 Participants n=5 Participants	455 Participants n=4 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	110 Participants n=7 Participants	101 Participants n=5 Participants	303 Participants n=4 Participants
Region of Enrollment United States	253 participants n=5 Participants	254 participants n=7 Participants	251 participants n=5 Participants	758 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 12 Weeks

Population: Full Analysis Set was used and was defined as all randomized participants who had both a baseline and at least 1 post-baseline value for high-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Outcome measures

Measure	ABT-335 and Rosuvastatin Calcium n=236 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=241 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)	23.0 percent change Standard Error 1.33	12.4 percent change Standard Error 1.32

PRIMARY outcome

Timeframe: Baseline to 12 Weeks

Population: Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Outcome measures

Measure	ABT-335 and Rosuvastatin Calcium n=236 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=241 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)	-40.3 percent change Standard Error 1.89	-17.5 percent change Standard Error 1.88

PRIMARY outcome

Timeframe: Baseline to 12 Weeks

Population: Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for low-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.

Outcome measures

Measure	ABT-335 and Rosuvastatin Calcium n=236 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=245 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)	-28.7 percent change Standard Error 1.33	-4.1 percent change Standard Error 1.31

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.

Outcome measures

Measure	ABT-335 and Rosuvastatin Calcium n=236 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=245 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)	-37.4 percent change Standard Error 1.06	-16.0 percent change Standard Error 1.05

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Outcome measures

Measure	ABT-335 and Rosuvastatin Calcium n=236 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=241 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)	-37.4 percent change Standard Error 1.06	-31.8 percent change Standard Error 1.05

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for VLDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Outcome measures

Measure	ABT-335 and Rosuvastatin Calcium n=235 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=239 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)	-41.3 percent change Standard Error 3.56	-22.2 percent change Standard Error 3.53

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for ApoB. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Outcome measures

Measure	ABT-335 and Rosuvastatin Calcium n=233 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=238 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)	-30.9 percent change Standard Error 1.00	-26.4 percent change Standard Error 0.99

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for hsCRP. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Outcome measures

Measure	ABT-335 and Rosuvastatin Calcium n=235 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=240 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)	-28.0 percent change Interval -49.1 to 9.0	-11.4 percent change Interval -37.4 to 26.8

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for total cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Outcome measures

Measure	ABT-335 and Rosuvastatin Calcium n=236 Participants ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=241 Participants Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)	-28.1 percent change Standard Error 0.85	-25.0 percent change Standard Error 0.84

Adverse Events

ABT-335 and Rosuvastatin Calcium

Serious events: 7 serious events

Other events: 52 other events

Deaths: 0 deaths

ABT-335

Serious events: 6 serious events

Other events: 41 other events

Deaths: 0 deaths

Rosuvastatin Calcium

Serious events: 4 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	ABT-335 and Rosuvastatin Calcium n=253 participants at risk ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	ABT-335 n=254 participants at risk ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=251 participants at risk Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Cardiac disorders Acute myocardial infarction	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.40% 1/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Cardiac disorders Cardiogenic shock	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.40% 1/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Cardiac disorders Coronary artery disease	0.79% 2/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.39% 1/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Cardiac disorders Myocardial infarction	0.40% 1/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.40% 1/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
General disorders Chest pain	0.40% 1/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
General disorders Cyst	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.39% 1/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Infections and infestations Bronchitis	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.39% 1/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.40% 1/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.40% 1/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.39% 1/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage unspecified	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.40% 1/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Nervous system disorders Aphasia	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.39% 1/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.39% 1/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Nervous system disorders Haemorrhage intracranial	0.40% 1/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Nervous system disorders Transient ischaemic attack	0.40% 1/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Psychiatric disorders Anxiety	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.40% 1/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Psychiatric disorders Mental status changes	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.39% 1/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.40% 1/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.00% 0/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.40% 1/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.

Other adverse events

Measure	ABT-335 and Rosuvastatin Calcium n=253 participants at risk ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	ABT-335 n=254 participants at risk ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks	Rosuvastatin Calcium n=251 participants at risk Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Gastrointestinal disorders Dyspepsia	6.3% 16/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	2.4% 6/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	0.80% 2/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Infections and infestations Nasopharyngitis	2.4% 6/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	5.9% 15/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	3.2% 8/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Musculoskeletal and connective tissue disorders Back pain	4.3% 11/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	4.3% 11/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	5.6% 14/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Nervous system disorders Headache	11.1% 28/253 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	9.1% 23/254 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.	12.7% 32/251 • Up to 23 weeks All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER