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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00680017

First received: May 15, 2008

Last updated: September 27, 2012

Last verified: September 2012

History of Changes

Results First Received: April 25, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Dyslipidemia Kidney Disease
Interventions:	Drug: ABT-335 plus rosuvastatin Drug: Rosuvastatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
280 participants were randomized and treated at 84 sites in the United States and Puerto Rico between 23 July 2008 and 02 March 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

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

Participant Flow: Overall Study

	ABT-335 Plus Rosuvastatin	Rosuvastatin
STARTED	140	140
COMPLETED	123	128
NOT COMPLETED	17	12
Adverse Event	13	7
Withdrawal by Subject	2	5
Lost to Follow-up	2	0

Baseline Characteristics

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Reporting Groups

	Description
ABT-335 Plus Rosuvastatin	ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
Rosuvastatin	Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Total	Total of all reporting groups

Baseline Measures

	ABT-335 Plus Rosuvastatin	Rosuvastatin	Total
Number of Participants [units: participants]	140	140	280
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	67	48	115
>=65 years	73	92	165
Age [units: years] Mean ± Standard Deviation	65.1 ± 10.35	67.4 ± 11.15	66.2 ± 10.80
Gender [units: participants]
Female	78	71	149
Male	62	69	131
Region of Enrollment [units: participants]
United States	129	132	261
Puerto Rico	11	8	19

Outcome Measures

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1. Primary:

Median Percent Change in Triglycerides From Baseline to Week 8. [ Time Frame: Baseline to 8 weeks ]

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2. Secondary:

Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8. [ Time Frame: Baseline to 8 weeks ]

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Serious Adverse Events

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Time Frame	24 weeks
Additional Description	Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent serious adverse events were collected from the time the participant signed the informed consent until 30 calendar days following discontinuation of study drug.

Reporting Groups

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

Serious Adverse Events

	ABT-335 Plus Rosuvastatin	Rosuvastatin
Total, serious adverse events
# participants affected / at risk	9/140 (6.43%)	11/140 (7.86%)
Cardiac disorders
Acute Coronary Syndrome ¹
# participants affected / at risk	1/140 (0.71%)	0/140 (0.00%)
Acute Myocardial Infarction ¹
# participants affected / at risk	1/140 (0.71%)	0/140 (0.00%)
Angina Unstable ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Coronary Artery Disease ¹
# participants affected / at risk	0/140 (0.00%)	3/140 (2.14%)
Myocardial Infarction ¹
# participants affected / at risk	0/140 (0.00%)	2/140 (1.43%)
Gastrointestinal disorders
Abdominal Pain ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Abdominal Pain Upper ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Nausea ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Upper Gastrointestinal Haemorrhage ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Vomiting ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
General disorders
Chest Pain ¹
# participants affected / at risk	1/140 (0.71%)	1/140 (0.71%)
Pyrexia ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Hepatobiliary disorders
Cholecystitis ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Infections and infestations
Gastroenteritis ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Gastroenteritis Viral ¹
# participants affected / at risk	1/140 (0.71%)	0/140 (0.00%)
Osteomyelitis ¹
# participants affected / at risk	1/140 (0.71%)	0/140 (0.00%)
Pneumonia ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Sepsis ¹
# participants affected / at risk	1/140 (0.71%)	0/140 (0.00%)
Metabolism and nutrition disorders
Hyperkalaemia ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Hypoglycaemia ¹
# participants affected / at risk	1/140 (0.71%)	0/140 (0.00%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion ¹
# participants affected / at risk	1/140 (0.71%)	0/140 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant ¹
# participants affected / at risk	1/140 (0.71%)	0/140 (0.00%)
Nervous system disorders
Thalamic infarction ¹
# participants affected / at risk	1/140 (0.71%)	0/140 (0.00%)
Renal and urinary disorders
Haematuria ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Urinary retention ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)
Respiratory, thoracic and mediastinal disorders
Pleuritic pain ¹
# participants affected / at risk	0/140 (0.00%)	1/140 (0.71%)

1	Term from vocabulary, MedDRA 13.1

Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
phone: +44 1509 645 895
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00680017 History of Changes
Other Study ID Numbers:	M10-313
Study First Received:	May 15, 2008
Results First Received:	April 25, 2012
Last Updated:	September 27, 2012
Health Authority:	United States: Food and Drug Administration

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