An 8-week, Randomized, Phase 2, Double-blind, Sequential Parallel-group Comparison Study Of Two Dose Levels Of Pf 06372865 Compared To Placebo As An Adjunctive Treatment In Outpatients With Inadequate Response To Standard Of Care For Generalized Anxiety Disorder
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Pfizer
- Enrollment
- 90
- Locations
- 43
- Primary Endpoint
- Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2
Study Overview
Brief Summary
This study aims to evaluate whether PF-06372865 is safe and effective in the treatment of sub-optimally controlled symptoms of generalized anxiety disorder during two 4-week treatment periods using a Sequential Parallel Comparison Design (SPCD). The study will use the Hamilton Anxiety Rating Scale (HAM-A) to measure change in symptoms from baseline for two doses of PF-06372865 compared to placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PF 06372865 2.5 mg BID then placebo.
PF 06372865 2.5 mg tablet 2 times daily for 4 weeks (Stage 1), followed by placebo 2 times daily for 4 weeks (Stage 2).
Intervention: PF-06372865. (Drug)
PF 06372865 7.5 mg BID then placebo.
PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 1), followed by placebo (2 times daily) for 4 weeks (Stage 2).
Intervention: PF-06372865. (Drug)
Placebo then PF 06372865 2.5 mg BID.
Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for 4 weeks
Intervention: PF-06372865. (Drug)
Placebo then PF 06372865 7.5 mg BID.
Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 2).
Intervention: PF-06372865. (Drug)
Placebo followed by placebo.
Placebo 2 times daily for 4 weeks (Stage 1) followed by Placebo 2 times daily for 4 weeks (Stage 2).
Intervention: PF-06372865. (Drug)
Outcomes
Primary Outcomes
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2
Time Frame: Stage 1: Week 4, Stage 2: Week 8
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2
Time Frame: Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1
Time Frame: Week 4
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Secondary Outcomes
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1(Week 1, 2, 3)
- Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2(Stage 1: Week 4, Stage 2: Week 8)
- Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2(Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8))
- Plasma Concentration Versus Time Summary of PF-06372865: Stage 1(Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4)
- Plasma Concentration Versus Time Summary of PF-06372865: Stage 2(Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8)
- Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8(Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8))
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2(Week 5, 6, 7, 8)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2(Stage 1: Week 4, Stage 2: Week 8)
- Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2(Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8))
- Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8(Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8))
- Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2(Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28))
- Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores(Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8)