A 52-WEEK OPEN-LABEL SAFETY STUDY OF PD 0332334 IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-004443-11-HU
• Date of registration: 10/11/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: A 52-WEEK OPEN-LABEL SAFETY STUDY OF PD 0332334 IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER
• Scientific title: A 52-WEEK OPEN-LABEL SAFETY STUDY OF PD 0332334 IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER
• Date of first enrolment: 04/02/2009
• Target sample size: 2289
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004443-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

1. Subjects must have completed all phases of one of the four preceding double-blind GAD studies (A5361017, A5361018, A5361019, or A5361020);

2. Female subjects must continue to use adequate birth control methods and have a negative serum pregnancy test at least 14 days (±3 day window) prior to and a negative urine pregnancy test before starting open label PD 0332334 at Visit 1 (Day 1);

3. Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;

4. There must be evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects presenting with any of the following will not be included in the study:
1. Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsor’s medical monitor;
2. Subjects who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsor’s medical monitor, would make it unsafe for the subject to participate in the study;
3. Serious suicidal risk per the clinical investigator’s judgment;
4. Current use of psychotropic medications primarily indicated for the treatment of GAD that cannot be discontinued after informed consent is obtained and at least 5 half-lives of the specific psychotropic medication used prior to Visit 1 (Day 1) in protocol A5361022;
5. Current use of benzodiazepines, gabapentin (Neurontin®), pregabalin (Lyrica®), or CNS drug or supplements with known or suspected sedating effects (eg, amitriptyline, antihistamines, carbamazepine, mirtazapine, trazodone, valproic acid) that cannot be discontinued after informed consent is obtained and at least 5 half-lives of the specific psychotropic medication used prior to Visit 1 (Day 1) in protocol A5361022. If there are questions regarding a potentially sedating CNS drug or supplement that is not listed, the site should contact the sponsor’s medical monitor to discuss.
6. Subjects with a positive urine drug test at the screen visit for any of the following substances or classes of compounds: amphetamines, barbiturates, opiates, benzodiazepines, sedatives and hypnotics, cocaine, phencyclidine (PCP), cannabinoids, or other illegal or illicit drugs. An exception to the exclusion for a positive benzodiazepine, opiate, or sedative and hypnotic drug test at the screen visit or Visit 1 (Day 1) may be granted by the medical monitor if written evidence of a valid, current prescription is presented;
7. Subjects with a screening 12-lead ECG demonstrating QTcF (Fredericia’s correction) >450 msec, if confirmed with an unscheduled repeat 12-lead ECG at the screen visit. In the event of discrepant QTcF values (ie, >450 msec and <450 msec) after repeat unscheduled 12-lead ECG at screen, a decision with regards to protocol eligibility will be made on a case by case basis between the investigator and the medical monitor;
8. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of the study;
9. Treatment with an investigational drug (other than a trial including PD 0332334) within 60 days preceding the first dose of trial medication;
10. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Generalized Anxiety Disorder
MedDRA version: 9.1 Level: LLT Classification code 10018105 Term: Generalized anxiety disorder

Intervention(s)

Product Code: PD-0332334
Pharmaceutical Form: Capsule, hard
Current Sponsor code: PD-0332334
Other descriptive name: (3S,5R)-3-amino-5-methyloctanoic acid hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Code: PD-0332334
Pharmaceutical Form: Capsule, hard
Current Sponsor code: PD-0332334
Other descriptive name: (3S,5R)-3-amino-5-methyloctanoic acid hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: Secondary Objectives:

• To assess the relationship between severity of GAD and health care utilization over a one year time period.

Primary end point(s): 2.2.1. Safety Endpoints
This safety study has multiple safety endpoints. Safety endpoints will include:
The nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; adverse events occurring during and after trial medication discontinuation; body weight, clinical safety laboratory, 12-lead ECGs, physical exams, and vital signs will be monitored in this study. During adverse event monitoring, it is expected that investigators will be alert to adverse events that are suicide related adverse events. If a suicide related adverse events is identified,
the investigator should consult the sponsor immediately regarding the continuation of the subject in the trial and a suicide risk assessment should be performed to determine appropriate clinical follow up. This assessment should be performed by a clinician (eg, MD, social worker, nurse) with experience in suicide risk assessment. If a suicide related adverse events is identified the investigational staff are asked to complete the Columbia Suicide Severity Rating Scale as an unplanned CRF page. This information will then be used to generate a narrative of the suicide related adverse event. In addition Pfizer will periodically perform a search of the safety database to identify any further suicidal related adverse events.

2.2.2. Other Endpoints
• Health care utilization will be assessed with the Health Care Utilization Questionnaire (HCU).
• GAD symptom severity will be measured by the HAM-A, the CGI-S, and the Daily Diary.
• At a select number of sites 2 PK samples will be collected at Visit 4 (Week 4). The first sample will be collected immediately upon arrival at the clinic and the second sample will be collected just prior to leaving the clinic.

Main Objective: Primary Objectives:

• To assess the long-term safety and tolerability of 350 to 600 mg/day of
PD-0332334 dosed BID in subjects with GAD.

Secondary ID(s)

A5361022