An Active-Controlled Extension Study to NCT01155466 [P049... | NCT01215227

NCT01215227

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2009-015162-57	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preladenant 2 mg	Experimental	Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 will continue to receive preladenant 2 mg in this extension study. Participants will receive 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.	Drug: Preladenant Drug: Placebo to rasagiline
Preladenant 5 mg	Experimental	Participants who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 will continue to receive preladenant 5 mg in this extension study. Participants will receive 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.	Drug: Preladenant Drug: Placebo to rasagiline
Preladenant 5 mg (on placebo in parent study)	Experimental	Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 will receive preladenant 5 mg in this extension study. Participants will receive 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.	Drug: Preladenant Drug: Placebo to rasagiline
Preladenant 10 mg	Experimental	Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 will continue to receive preladenant 10 mg in this extension study. Participants will receive 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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preladenant	Drug	Daily for 40 weeks: 2, 5, or 10 mg preladenant tablet each morning; 2, 5, or 10 mg preladenant tablet each evening (approximately 8 hours after the morning dose)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Systolic Blood Pressure ≥180 mmHg	The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).	Up to 42 weeks
Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg	The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).	Up to 42 weeks
Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline	The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.	Up to 42 weeks
Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline	The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.	Up to 42 weeks
Percentage of Participants With Suicidality

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants who have completed the 12-week treatment period of the parent trial, P04938 or P07037.
Participants must be willing and able to provide written informed consent for P06153.
Participants must be able to adhere to dose and visit schedules.
Participants must be taking L-dopa.
Participants may be taking additional adjunct PD medications (e.g., dopamine agonists, entacapone).
Each participant must have results of clinical laboratory tests (hematology, blood chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator as evidenced by the last available test results from the parent study (P04938 or P07037), and no results fall within the parameters for exclusion described below in the exclusion criterion for liver-related findings.
There has been no change in, or there has been no finding to warrant checking, serology status (for cytomegalovirus [CMV], Epstein-Barr virus [EBV], and Hepatitis B, C, and E).
Each participant must have results of a physical examination within normal limits, including blood pressure, within normal limits or clinically acceptable limits to the investigator, and not within the parameters for exclusion described below in the exclusion criterion for blood pressure.
All participants who are sexually active or plan to be sexually active agree to use a highly effective method of birth control while the participant is in the study and for 2 weeks after the last dose of study drug. A male participant must not donate sperm within 2 weeks after the last dose of study drug.

Exclusion Criteria:

Any participant who discontinued from P04938 or P07037 for any reason.
Any participant with a severe or ongoing unstable medical condition (e.g., any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence).
Any participant with a history of poorly controlled diabetes (e.g., hemoglobin A1c > 8.5) or significantly abnormal renal function (e.g., creatinine > 2.0 mg/dL) in the opinion of the investigator.
As a continuation of the liver-related withdrawal criteria from the parent studies (P04938 and P07037), any participant with elevated values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (T BIL), as evidenced by the most recent chemistry panel results in the parent study, meeting any one of the following criteria:
ALT or AST > 8 x upper limit of normal (ULN).
ALT or AST > 5 x ULN for more than 2 weeks.
ALT or AST > 3 x ULN and (T-BIL > 2 x ULN or international normalized ratio [INR] > 1.5 that is not due to anti-coagulation) at the same visit.
ALT or AST > 3 x ULN with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%).
As a continuation of the blood pressure (BP) withdrawal criteria from the parent study (P04938 or P07037), any participant meeting the following criteria for the second of two consecutive visits separated by 7 days (i.e., the participant met one of the BP criteria once already, 7 days before the P06153 screening visit):
Systolic BP ≥ 180 mm Hg or diastolic BP ≥ 105 mm Hg, or
An elevation from baseline BP in the parent study (P04938 or P07037) of systolic BP >= 40 mm Hg or diastolic BP ≥ 20 mm Hg.
A participant must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection.
Any participant with an average daily consumption of more than three 4-ounce glasses (118 mL) of wine or the equivalent.
A participant must not have received certain prespecified medications or ingested high tyramine-containing aged cheeses (e.g., Stilton) for a prespecified time window before the trial, during the trial, and for 2 weeks after the trial.
Any participant with allergy/sensitivity to the investigational products or their excipients.
Any female participant breast feeding or considering breast feeding.
Any female participant pregnant or intending to become pregnant.
Any participant with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
Any participant with a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.
FG002	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.
FG003	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.
FG004	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.
FG005	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Systolic Blood Pressure ≥180 mmHg

The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).

All Participants as Treated (APaT) population, which consisted of all participants who received at least one dose of study drug.

Posted

Number

Percentage of participants

Up to 42 weeks

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
C539997	2-(2-furanyl)-7-(2-(4-(4-(2-methoxyethoxy)phenyl)-1-piperazinyl)ethyl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidine-5-amine
C031967	rasagiline