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Study recruitment was terminated on 24 June 2015, due to a Pfizer business decision. This study was not terminated for reasons of safety or efficacy
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF 06372865 2.5 mg BID then placebo. | Experimental | 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). |
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| PF 06372865 7.5 mg BID then placebo. | Experimental | 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). |
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| Placebo then PF 06372865 2.5 mg BID. | Experimental | Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for 4 weeks |
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| Placebo then PF 06372865 7.5 mg BID. | Experimental | 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). |
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| Placebo followed by placebo. | Placebo Comparator | Placebo 2 times daily for 4 weeks (Stage 1) followed by Placebo 2 times daily for 4 weeks (Stage 2). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06372865. | Drug | Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 | 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. | Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28) |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1 | 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. | Week 4 |
| Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 | 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. | Stage 1: Week 4, Stage 2: Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Clinical Development, Inc. | Cerritos | California | 90703 | United States | ||
| Pharmacology Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29721364 | Derived | Targum SD, Murphy C, Khan J, Zumpano L, Whitlock M, Simen AA, Binneman B. Audio Recording for Independent Confirmation of Clinical Assessments in Generalized Anxiety Disorder. Innov Clin Neurosci. 2018 Apr 1;15(3-4):37-42. |
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This was a sequential parallel study consisting of 2 stages: 4 week randomized treatment period (Stage 1) followed by a 4 week treatment period (Stage 2). Participants randomized to placebo for Stage 1, received either PF-06372865 or placebo in Stage 2 and participants randomized to PF-06372865 in Stage 1 were assigned to Placebo in Stage 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Placebo | Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2. |
| FG001 | Placebo + PF-06372865 2.5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 ( 4 Weeks) |
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| Week 5, 6, 7, 8 |
| Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment. | Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28) |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment. | Stage 1: Week 4, Stage 2: Week 8 |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | 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. | Week 1, 2, 3 |
| Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 | A responder was defined as a participant with >= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). 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. Percentage of responders of total HMA scale were reported. | 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 | CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline. | 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 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 | The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, "Considering your total clinical experience with that particular population, how mentally ill was your participant at that time?" Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity. | 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 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0. | 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 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. | 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): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | The HAM-A scale was a clinician interview-administered 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. Psychic subscale of the HAM-A was the sum of 7 items. 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 28 (very severe), where lower scores indicates less anxiety. | 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): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | The HAM-A scale was a clinician interview-administered 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. Somatic subscale of the HAM-A was the sum of 7 items. 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 28 (very severe), where lower scores indicates less anxiety. | 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) |
| Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores | Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). 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. | Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8 |
| Encino |
| California |
| 91316 |
| United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| Excell Research, Inc. | Oceanside | California | 92056 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| California Neuorpsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) | San Diego | California | 92102 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Institute of Living | Hartford | Connecticut | 06106 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Gulfcoast Clinical Center | Fort Meyers | Florida | 33912 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Berma Research Group | Hialeah | Florida | 33016 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Sarkis Clinical Trials | Lake City | Florida | 32025 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| Institute for Advanced Medical Research | Alpharetta | Georgia | 30005 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Northwest Behavioral Research Center | Roswell | Georgia | 30076 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Phoenix Medica Research, Inc | Prairie Village | Kansas | 66206 | United States |
| Pharmasite Research Inc | Baltimore | Maryland | 21208 | United States |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | United States |
| ActivMed Practices & Research, Inc | Methuen | Massachusetts | 01844 | United States |
| BCCR Trials | Natick | Massachusetts | 07160 | United States |
| Premier Psychiatric Research Institute. LLC. | Lincoln | Nebraska | 68526 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| SPRI Clinical Trials LLC | Brooklyn | New York | 11235 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Comprehensive Clinical Development, Inc. | Jamaica | New York | 11432 | United States |
| Bioscience Research LLC | Mount Kisco | New York | 10549 | United States |
| Fieve Clinical Research, Inc | New York | New York | 10168 | United States |
| Patient Priority Clinical Sites, LLC | Cincinnati | Ohio | 45215 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45227 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Futuresearch Trials of Dallas | Dallas | Texas | 75231 | United States |
| InSite Clinical Research, LLC | DeSoto | Texas | 75115 | United States |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Summit Research Network (Seattle) LLC | Seattle | Washington | 98104 | United States |
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 milligram (mg) tablet twice daily for 4 weeks during Stage 2.
| FG002 | Placebo + PF-06372865 7.5 mg | Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2. |
| FG003 | PF-06372865 2.5 mg + Placebo | Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2. |
| FG004 | PF-06372865 7.5 mg + Placebo | Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Stage 2 (4 Weeks) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Placebo | Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2. |
| BG001 | Placebo + PF-06372865 2.5 mg | Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 2. |
| BG002 | Placebo + PF-06372865 7.5 mg | Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2. |
| BG003 | PF-06372865 2.5 mg + Placebo | Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2. |
| BG004 | PF-06372865 7.5 mg + Placebo | Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| 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 | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 | 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. | Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) with less than (<) 50% reduction in HAM-A during Stage 1 baseline,Week 4 and HAM-A value of greater than or equal to (>=)16 at Week 4. | Posted | Mean | Standard Deviation | units on a scale | Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28) |
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| Primary | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1 | 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. | Full analysis set for Stage 1 included all randomized participants who had received at least 1 dose of randomized treatment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 4 |
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| Primary | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 | 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. | Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Stage 1: Week 4, Stage 2: Week 8 |
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| Secondary | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | 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. | Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) < 50 % reduction in HAM-A during Stage 1 baseline, Week 4 and HAM-A value of >=16 at Week 4. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 5, 6, 7, 8 |
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| Secondary | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment. | Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28) |
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| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment. | Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Stage 1: Week 4, Stage 2: Week 8 |
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| Secondary | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | 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. | Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 1, 2, 3 |
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| Secondary | Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 | A responder was defined as a participant with >= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). 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. Percentage of responders of total HMA scale were reported. | Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Stage 1: Week 4, Stage 2: Week 8 |
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| Secondary | 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 | CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline. | Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | 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 | The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, "Considering your total clinical experience with that particular population, how mentally ill was your participant at that time?" Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity. | Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0. | Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4 |
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| Secondary | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. | Placebo Non-Responder set for Stage 2. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8 |
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| Secondary | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | The HAM-A scale was a clinician interview-administered 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. Psychic subscale of the HAM-A was the sum of 7 items. 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 28 (very severe), where lower scores indicates less anxiety. | Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | The HAM-A scale was a clinician interview-administered 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. Somatic subscale of the HAM-A was the sum of 7 items. 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 28 (very severe), where lower scores indicates less anxiety. | Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores | Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). 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. | Full analysis set for Stage 1 was defined as all participants randomized and who had received at least 1 dose of randomized treatment. The Stage 2 placebo non-responder set was defined as the subset of subjects in the Stage 2 placebo set who had both a <50% reduction in HAM-A between Stage 1 baseline and Week 4, and HAM-A value of >= 16 at Week 4. | Posted | Number | percentage of participants | Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8 |
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Not provided
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2. | 1 | 87 | 27 | 87 | ||
| EG001 | PF-06372865 2.5 mg | All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2. | 0 | 37 | 13 | 37 | ||
| EG002 | PF-06372865 7.5 mg | All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2. | 0 | 35 | 16 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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All 34 centres who enrolled subjects were terminated due to internal sponsor portfolio prioritization. The decision to terminate the study was not due to any safety concern or change in the benefit:risk assessment of PF-06372865
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630159 | PF-06372865 |
Not provided
Not provided
Not provided
| Other |
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| Adverse Event |
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| Protocol Violation |
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| Lost to Follow-up |
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| Male |
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| OG003 | Placebo (Stage 2) | All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2. |
| OG004 | PF-06372865 2.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2. |
| OG005 | PF-06372865 7.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1. |
| OG003 | Placebo (Stage 2) | All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2. |
| OG004 | PF-06372865 2.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2. |
| OG005 | PF-06372865 7.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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|
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1. |
| OG003 | Placebo (Stage 2) | All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2. |
| OG004 | PF-06372865 2.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2. |
| OG005 | PF-06372865 7.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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| PF-06372865 7.5 mg (Stage 1) |
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1. |
| OG003 | Placebo (Stage 2) | All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2. |
| OG004 | PF-06372865 2.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2. |
| OG005 | PF-06372865 7.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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|
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1. |
| OG003 | Placebo (Stage 2) | All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2. |
| OG004 | PF-06372865 2.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2. |
| OG005 | PF-06372865 7.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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|
| OG002 |
| PF-06372865 7.5 mg (Stage 1) |
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1. |
| OG003 | Placebo (Stage 2) | All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2. |
| OG004 | PF-06372865 2.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2. |
| OG005 | PF-06372865 7.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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| Participants |
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All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1. |
| OG003 | Placebo (Stage 2) | All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2. |
| OG004 | PF-06372865 2.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2. |
| OG005 | PF-06372865 7.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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|
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1. |
| OG003 | Placebo (Stage 2) | All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2. |
| OG004 | PF-06372865 2.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2. |
| OG005 | PF-06372865 7.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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| OG002 | PF-06372865 7.5 mg (Stage 1) | All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1. |
| OG003 | Placebo (Stage 2) | All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2. |
| OG004 | PF-06372865 2.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2. |
| OG005 | PF-06372865 7.5 mg (Stage 2) | All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2. |
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