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An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01215227
First received: October 4, 2010
Last updated: October 18, 2016
Last verified: October 2016
Results First Received: October 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Parkinson Disease
Idiopathic Parkinson Disease
Interventions: Drug: Preladenant
Drug: Rasagiline
Drug: Placebo to preladenant
Drug: Placebo to rasagiline

  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
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
Preladenant 2 mg Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Preladenant 5 mg Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Preladenant 5 mg (on Placebo in Parent Study) Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Preladenant 10 mg Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Rasagiline 1 mg Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Rasagiline 1 mg (on Placebo in Parent Study) Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.

Participant Flow:   Overall Study
    Preladenant 2 mg   Preladenant 5 mg   Preladenant 5 mg (on Placebo in Parent Study)   Preladenant 10 mg   Rasagiline 1 mg   Rasagiline 1 mg (on Placebo in Parent Study)
STARTED   218   215   107   97   93   109 
Treated   218   215   106   96   93   108 
COMPLETED   97   96   50   48   45   51 
NOT COMPLETED   121   119   57   49   48   58 
Adverse Event                11                11                4                8                7                6 
Treatment Failure                8                4                1                5                1                1 
Lost to Follow-up                1                4                1                1                1                2 
Subject Withdrew Consent                16                20                7                10                11                8 
Non-Compliance With Protocol                2                6                1                0                0                0 
Administrative                83                73                42                24                28                40 
Missing Status                0                1                0                0                0                0 
Randomized but not treated                0                0                1                1                0                1 



  Baseline Characteristics
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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.
All Participants as Treated: All participants who received at least one dose of study drug in Extension Study P06153. Data were not reported for 3 participants who were randomized but not treated.

Reporting Groups
  Description
Preladenant 2 mg Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Preladenant 5 mg Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Preladenant 5 mg (on Placebo in Parent Study) Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Preladenant 10 mg Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Rasagiline 1 mg Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Rasagiline 1 mg (on Placebo in Parent Study) Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Total Total of all reporting groups

Baseline Measures
   Preladenant 2 mg   Preladenant 5 mg   Preladenant 5 mg (on Placebo in Parent Study)   Preladenant 10 mg   Rasagiline 1 mg   Rasagiline 1 mg (on Placebo in Parent Study)   Total 
Overall Participants Analyzed 
[Units: Participants]
 218   215   106   96   93   108   836 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.4  (8.5)   63.0  (8.7)   64.4  (8.7)   63.9  (8.0)   63.8  (9.9)   63.9  (7.8)   63.3  (8.6) 
Gender 
[Units: Participants]
             
Female   68   100   55   40   37   41   341 
Male   150   115   51   56   56   67   495 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Systolic Blood Pressure ≥180 mmHg   [ Time Frame: Up to 42 weeks ]

2.  Primary:   Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg   [ Time Frame: Up to 42 weeks ]

3.  Primary:   Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline   [ Time Frame: Up to 42 weeks ]

4.  Primary:   Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline   [ Time Frame: Up to 42 weeks ]

5.  Primary:   Percentage of Participants With Suicidality   [ Time Frame: Up to 42 weeks ]

6.  Primary:   Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40   [ Time Frame: Baseline and Week 40 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This study was terminated early due to the lack of efficacy of preladenant in the parent studies NCT1155466 and NCT01227265.


  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:
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: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01215227     History of Changes
Other Study ID Numbers: P06153
2009-015162-57 ( EudraCT Number )
Study First Received: October 4, 2010
Results First Received: October 18, 2016
Last Updated: October 18, 2016