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AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00474240
Recruitment Status : Completed
First Posted : May 16, 2007
Results First Posted : February 21, 2013
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Drug: Atorvastatin 20 mg
Drug: AEGR-733 5 mg
Drug: AEGR-733 10 mg
Drug: Placebo
Drug: AEGR-733 5 mg + atorvastatin 20 mg
Drug: AEGR-733 10 mg + atorvastatin 20 mg
Enrollment 157
Recruitment Details The study was performed from 05 November 2007 to 04 August 2008 at 17 medical clinics within the United States.
Pre-assignment Details Subjects who were previously on a lipid lowering therapy underwent a 5-week washout period. All subjects were on a low-fat diet (<30% calories from fat) starting 5 weeks prior to study drug treatment and continuing for the duration of the study.
Arm/Group Title Placebo Atorvastatin 20 mg AEGR-733 5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 10 mg + Atorvastatin 20 mg
Hide Arm/Group Description Placebo capsule taken orally once daily Atorvastatin 20 mg taken orally once daily AEGR-733 5 mg taken orally once daily AEGR-733 10 mg taken orally once daily One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
Period Title: Overall Study
Started 27 26 26 26 26 26
Completed 26 25 17 10 18 8
Not Completed 1 1 9 16 8 18
Reason Not Completed
Withdrawal by Subject             1             1             0             2             3             1
Adverse Event             0             0             9             14             5             16
Removed due to lab value             0             0             0             0             0             1
Arm/Group Title Placebo Atorvastatin 20 mg AEGR-733 5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 10 mg + Atorvastatin 20 mg Total
Hide Arm/Group Description Placebo capsule taken orally once daily Atorvastatin 20 mg taken orally once daily AEGR-733 5 mg taken orally once daily AEGR-733 10 mg taken orally once daily One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily Total of all reporting groups
Overall Number of Baseline Participants 27 26 26 26 26 26 157
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 26 participants 26 participants 26 participants 26 participants 26 participants 157 participants
53  (11.1) 56  (8.4) 56  (8.3) 54  (11.6) 51  (10.1) 53  (9.7) 54  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 26 participants 26 participants 26 participants 26 participants 157 participants
Female
13
  48.1%
16
  61.5%
16
  61.5%
16
  61.5%
10
  38.5%
16
  61.5%
87
  55.4%
Male
14
  51.9%
10
  38.5%
10
  38.5%
10
  38.5%
16
  61.5%
10
  38.5%
70
  44.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 26 participants 26 participants 26 participants 26 participants 157 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
   3.8%
3
  11.5%
3
  11.5%
0
   0.0%
7
   4.5%
Not Hispanic or Latino
27
 100.0%
26
 100.0%
25
  96.2%
23
  88.5%
23
  88.5%
26
 100.0%
150
  95.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 26 participants 26 participants 26 participants 26 participants 157 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.8%
1
   0.6%
Asian
1
   3.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  14.8%
5
  19.2%
2
   7.7%
4
  15.4%
5
  19.2%
3
  11.5%
23
  14.6%
White
22
  81.5%
21
  80.8%
23
  88.5%
21
  80.8%
18
  69.2%
22
  84.6%
127
  80.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   3.8%
1
   3.8%
3
  11.5%
0
   0.0%
5
   3.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 26 participants 26 participants 26 participants 26 participants 26 participants 157 participants
27 26 26 26 26 26 157
1.Primary Outcome
Title Percent Change From Baseline in LDL-C at 8 Weeks
Hide Description [Not Specified]
Time Frame Atfer 8 weeks on study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat
Arm/Group Title Placebo Atorvastatin 20 mg AEGR-733 5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 10 mg + Atorvastatin 20 mg
Hide Arm/Group Description:
Placebo capsule taken orally once daily
Atorvastatin 20 mg taken orally once daily
AEGR-733 5 mg taken orally once daily
AEGR-733 10 mg taken orally once daily
One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
Overall Number of Participants Analyzed 25 24 18 10 18 9
Mean (Standard Deviation)
Unit of Measure: Percent Change
2  (11.2) -42  (16.4) -16  (17.3) -37  (23.0) -47  (19.2) -50  (28.0)
2.Secondary Outcome
Title Percent Change From Baseline of Other Lipids
Hide Description [Not Specified]
Time Frame After 8 weeks of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat
Arm/Group Title Placebo Atorvastatin 20 mg AEGR-733 5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 10 mg + Atorvastatin 20 mg
Hide Arm/Group Description:
Placebo capsule taken orally once daily
Atorvastatin 20 mg taken orally once daily
AEGR-733 5 mg taken orally once daily
AEGR-733 10 mg taken orally once daily
One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
Overall Number of Participants Analyzed 26 25 19 10 18 9
Mean (Standard Deviation)
Unit of Measure: Percent
Percent change from baseline in total cholesterol 2  (9.9) -30  (12.4) -18  (14.6) -33  (19.0) -37  (15.3) -40  (20.7)
Percent change from baseline in total Apo B 0  (11.0) -34  (13.0) -17  (12.4) -36  (21.9) -41  (16.9) -46  (19.8)
Percent change from baseline in non-HDL-C 2  (10.3) -38  (15.8) -19  (17.1) -36  (26.0) -45  (17.7) -48  (24.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Atorvastatin 20 mg AEGR-733 5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 10 mg + Atorvastatin 20 mg
Hide Arm/Group Description Placebo capsule taken orally once daily Atorvastatin 20 mg taken orally once daily AEGR-733 5 mg taken orally once daily AEGR-733 10 mg taken orally once daily One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
All-Cause Mortality
Placebo Atorvastatin 20 mg AEGR-733 5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 10 mg + Atorvastatin 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Atorvastatin 20 mg AEGR-733 5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 10 mg + Atorvastatin 20 mg
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   0/27 (0.00%)      0/26 (0.00%)      1/26 (3.85%)      1/26 (3.85%)      0/26 (0.00%)      0/26 (0.00%)    
Cardiac disorders             
Myocardial infarction  0/27 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Atorvastatin 20 mg AEGR-733 5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 10 mg + Atorvastatin 20 mg
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   17/27 (62.96%)      15/26 (57.69%)      23/26 (88.46%)      23/26 (88.46%)      21/26 (80.77%)      24/26 (92.31%)    
Gastrointestinal disorders             
Diarrhoea  2/27 (7.41%)  2 2/26 (7.69%)  2 16/26 (61.54%)  16 15/26 (57.69%)  15 11/26 (42.31%)  11 20/26 (76.92%)  20
Nausea  1/27 (3.70%)  1 2/26 (7.69%)  2 5/26 (19.23%)  5 7/26 (26.92%)  7 5/26 (19.23%)  5 14/26 (53.85%)  14
Flatulence  2/27 (7.41%)  2 0/26 (0.00%)  0 1/26 (3.85%)  1 2/26 (7.69%)  2 4/26 (15.38%)  4 4/26 (15.38%)  4
Abdominal Distension  1/27 (3.70%)  1 1/26 (3.85%)  1 2/26 (7.69%)  2 2/26 (7.69%)  2 2/26 (7.69%)  2 4/26 (15.38%)  4
Nasopharyngitis  3/27 (11.11%)  3 2/26 (7.69%)  2 1/26 (3.85%)  1 0/26 (0.00%)  0 4/26 (15.38%)  4 1/26 (3.85%)  1
Dyspepsia  2/27 (7.41%)  2 2/26 (7.69%)  2 0/26 (0.00%)  0 1/26 (3.85%)  1 2/26 (7.69%)  2 2/26 (7.69%)  2
Abdominal Pain Upper  1/27 (3.70%)  1 0/26 (0.00%)  0 3/26 (11.54%)  3 3/26 (11.54%)  3 0/26 (0.00%)  0 1/26 (3.85%)  1
Abdominal Pain  0/27 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 1/26 (3.85%)  1 2/26 (7.69%)  2 3/26 (11.54%)  3
Vomiting  1/27 (3.70%)  1 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 1/26 (3.85%)  1 3/26 (11.54%)  3
Constipation  1/27 (3.70%)  1 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 2/26 (7.69%)  2 0/26 (0.00%)  0
Gastrooesophageal Reflux Disease  0/27 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 3/26 (11.54%)  3 0/26 (0.00%)  0
Eructation  1/27 (3.70%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2
Asthenia  0/27 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0
Gastric Dilatation  0/27 (0.00%)  0 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0
General disorders             
Chest Pain  0/27 (0.00%)  0 0/26 (0.00%)  0 3/26 (11.54%)  3 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0
Infections and infestations             
Urinary Tract Infection  1/27 (3.70%)  1 2/26 (7.69%)  2 0/26 (0.00%)  0 1/26 (3.85%)  1 1/26 (3.85%)  1 1/26 (3.85%)  1
Gastroenteritis Viral  1/27 (3.70%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 3/26 (11.54%)  3 0/26 (0.00%)  0
Upper Respiratory Tract Infection  0/27 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0
Investigations             
Aspartate aminotransferase increased  1/27 (3.70%)  1 1/26 (3.85%)  1 3/26 (11.54%)  3 2/26 (7.69%)  2 1/26 (3.85%)  1 0/26 (0.00%)  0
Alanine aminotransferase increased  1/27 (3.70%)  1 1/26 (3.85%)  1 2/26 (7.69%)  2 2/26 (7.69%)  2 1/26 (3.85%)  1 0/26 (0.00%)  0
Hepatice Enzyme Increased  0/27 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 1/26 (3.85%)  1 0/26 (0.00%)  0
Blood Urine  0/27 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 0/26 (0.00%)  0
Blood Potassium Increased  0/27 (0.00%)  0 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0
Metabolism and nutrition disorders             
Decreased Appetite  0/27 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 2/26 (7.69%)  2 1/26 (3.85%)  1 2/26 (7.69%)  2
Musculoskeletal and connective tissue disorders             
Muscle spasms  0/27 (0.00%)  0 2/26 (7.69%)  2 1/26 (3.85%)  1 2/26 (7.69%)  2 0/26 (0.00%)  0 2/26 (7.69%)  2
Nervous system disorders             
Headache  3/27 (11.11%)  3 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders             
Oropharyngeal Pain  1/27 (3.70%)  1 0/26 (0.00%)  0 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders             
Dry Skin  0/27 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0
Study AEGR-733-003, initiated in May 2007, was halted, and restarted under an amended Protocol in November 2007.
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.
Information is unavailable.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Aegerion Pharmaceuticals
Phone: 617-500-7867
Layout table for additonal information
Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00474240    
Other Study ID Numbers: AEGR-733-003
First Submitted: May 14, 2007
First Posted: May 16, 2007
Results First Submitted: January 18, 2013
Results First Posted: February 21, 2013
Last Update Posted: March 20, 2018