We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592240
First Posted: May 7, 2012
Last Update Posted: December 5, 2017
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.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: October 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: PBO
Drug: 200mg PF-04950615 (RN316)
Drug: 300mg PF-04950615 (RN316)
Drug: PF-04950615

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo: Every 14 Days Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
PF-04950615 50 mg: Every 14 Days Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
PF-04950615 100 mg: Every 14 Days Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
PF-04950615 150 mg: Every 14 Days Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
Placebo: Every 28 Days Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
PF-04950615 200 mg: Every 28 Days Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
PF-04950615 300 mg: Every 28 Days Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.

Participant Flow:   Overall Study
    Placebo: Every 14 Days   PF-04950615 50 mg: Every 14 Days   PF-04950615 100 mg: Every 14 Days   PF-04950615 150 mg: Every 14 Days   Placebo: Every 28 Days   PF-04950615 200 mg: Every 28 Days   PF-04950615 300 mg: Every 28 Days
STARTED   50   50   52   50   51   50   51 
COMPLETED   47   39   45   47   44   47   48 
NOT COMPLETED   3   11   7   3   7   3   3 
Adverse Event                1                0                0                1                1                0                0 
Death                0                1                0                0                0                0                0 
Lost to Follow-up                1                3                1                0                3                2                0 
Protocol Violation                0                0                0                0                0                1                0 
Withdrawal by Subject                0                4                4                1                3                0                2 
Other                0                3                1                1                0                0                1 
Did Not Meet Entrance Criteria                1                0                1                0                0                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) included all participants who were randomized.

Reporting Groups
  Description
Placebo: Every 14 Days Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
PF-04950615 50 mg: Every 14 Days Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
PF-04950615 100 mg: Every 14 Days Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
PF-04950615 150 mg: Every 14 Days Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
Placebo: Every 28 Days Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
PF-04950615 200 mg: Every 28 Days Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
PF-04950615 300 mg: Every 28 Days Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo: Every 14 Days   PF-04950615 50 mg: Every 14 Days   PF-04950615 100 mg: Every 14 Days   PF-04950615 150 mg: Every 14 Days   Placebo: Every 28 Days   PF-04950615 200 mg: Every 28 Days   PF-04950615 300 mg: Every 28 Days   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   52   50   51   50   51   354 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.5  (9.84)   59.1  (11.26)   61.9  (9.58)   61.4  (9.75)   58.4  (11.62)   60.3  (9.64)   60.2  (8.17)   60.3  (10.01) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      25  50.0%      26  52.0%      26  50.0%      29  58.0%      22  43.1%      31  62.0%      26  51.0%      185  52.3% 
Male      25  50.0%      24  48.0%      26  50.0%      21  42.0%      29  56.9%      19  38.0%      25  49.0%      169  47.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:   Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

4.  Secondary:   Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

5.  Secondary:   Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

6.  Secondary:   Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

7.  Secondary:   Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

8.  Secondary:   Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

9.  Secondary:   Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

10.  Secondary:   Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

11.  Secondary:   Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

12.  Secondary:   Change From Baseline in Total Cholesterol at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

13.  Secondary:   Percent Change From Baseline in Total Cholesterol at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

14.  Secondary:   Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

15.  Secondary:   Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

16.  Secondary:   Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

17.  Secondary:   Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

18.  Secondary:   Change From Baseline in Triglycerides at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

19.  Secondary:   Percent Change From Baseline in Triglycerides at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

20.  Secondary:   Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

21.  Secondary:   Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24   [ Time Frame: Baseline, Week 12, 24 ]

22.  Secondary:   Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)   [ Time Frame: Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups ]

23.  Secondary:   Percentage of Participants With Injection Site Adverse Events   [ Time Frame: Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups ]

24.  Secondary:   Plasma Concentration of PF-04950615 at Week 12 and 24   [ Time Frame: Week 12, 24 ]

25.  Secondary:   Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)   [ Time Frame: Week 12, 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
There were no limitations or caveats in this study.


  More Information
  Hide More Information

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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01592240     History of Changes
Other Study ID Numbers: B1481015
2012-001226-10 ( EudraCT Number )
First Submitted: May 3, 2012
First Posted: May 7, 2012
Results First Submitted: October 27, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017