HP-3070: Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.
Sponsor
Noven Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02876900
Collaborator
(none)
617
1
3
22
28.1
Study Details
Study Description
Brief Summary
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a Phase 3, randomized, double-blind, placebo-controlled, in-patient, efficacy, and safety study to evaluate HP-3070 for the treatment of schizophrenia.
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia, who are in an acute exacerbation and to assess the impacts of covariates on asenapine exposure as delivered in a patch formulation, using a population-based approach.
Study Design
Study Type:
Interventional
Actual Enrollment
:
617 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, 6-Week, In-Patient Study to Assess Efficacy and Safety of HP-3070 in Subjects Diagnosed With Schizophrenia
Actual Study Start Date
:
Aug 1, 2016
Actual Primary Completion Date
:
Jun 1, 2018
Actual Study Completion Date
:
Jun 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low dose Asenapine maleate patch Low dose asenapine maleate, transdermal patches will be compared against placebo patches. |
Drug: Low Dose Asenapine maleate transdermal patch
The study will evaluate low dose Asenapine maleate transdermal patch
Other Names:
Drug: Placebo
The study will evaluate placebo transdermal patch.
Other Names:
|
| Experimental: High dose asenapine maleate patch High dose asenapine maleate, transdermal patches will be compared against placebo patches. |
Drug: High Dose Asenapine maleate transdermal patch
The study will evaluate high dose Asenapine maleate transdermal patch
Other Names:
Drug: Placebo
The study will evaluate placebo transdermal patch.
Other Names:
|
| Placebo Comparator: Placebo transdermal patch Low dose or high dose asenapine maleate transdermal patch will be compared against placebo patches |
Drug: Placebo
The study will evaluate placebo transdermal patch.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Syndrome Scale (PANSS) Total Score: Change From Baseline to Week 6. [6 weeks]
To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by Positive and Negative Syndrome Scale (PANSS) total score. The PANSS total score is the sum of all 30 items (7 positive items, 7 negative items, and 16 general psychopathology items). For each item, severity was rated on an anchored 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. If one or more items are missing at a given assessment, the total score is set to missing. Total score ranges from 30 to 210. Score indicates severity of the disease, i.e. low score = low severity.
Secondary Outcome Measures
- Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Clinical Global Impression - Severity of Illness Scale: Change From Baseline to Week 6. [6 weeks]
To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by the Clinical Global Impression - Severity of Illness Scale. The severity of illness for each participant was rated using the CGI-S. The rater or Investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?". Response choices included: 0 = not assessed; 1 = normal, not at all ill, 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Current diagnosis of schizophrenia.
-
Subject has PANSS total score ≥80, AND score of 4 or more in at least 2 of the following PANSS items at Screening and at Baseline: conceptual disorganization delusions; hallucinatory behavior; unusual thought content.
-
Subjects must be able to wear a transdermal patch for 24 hours.
Exclusion Criteria:
-
Subject has been diagnosed with schizophrenia less than 6 months prior to Screening Visit.
-
Subject has received within 90 days of Screening Visit: electroconvulsive therapy; transcranial magnetic stimulation; vagal nerve stimulation; or other brain stimulation treatments
-
Subject has experienced acute depressive symptoms within 30 days prior to Screening Visit that requires treatment with an antidepressant, as determined by the Investigator.
-
Currently taking clozapine for the treatment of schizophrenia.
-
Has hypothyroidism or hyperthyroidism.
-
Subject is currently being treated with insulin for diabetes.
-
Subject has epilepsy or history of seizures.
-
Positive urine pregnancy test.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Noven Pharmaceuticals, Inc. | Jersey City | New Jersey | United States | 07310 |
Sponsors and Collaborators
- Noven Pharmaceuticals, Inc.
Investigators
- Study Director: George Harb, MD, MPH, Noven Pharmaceuticals, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Noven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02876900
Other Study ID Numbers:
- HP-3070-GL-04
First Posted:
Aug 24, 2016
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Low Dose Asenapine Maleate Patch | High Dose Asenapine Maleate Patch | Placebo Patch |
|---|---|---|---|
| Arm/Group Description | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch. Placebo: Evaluate Low Dose versus Placebo. | High dose asenapine maleate, transdermal patches will be compared against placebo patches. High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch Placebo: Evaluate High Dose versus Placebo. | Placebo transdermal patch |
| Period Title: Overall Study | |||
| STARTED | 205 | 206 | 206 |
| COMPLETED | 166 | 158 | 162 |
| NOT COMPLETED | 39 | 48 | 44 |
Baseline Characteristics
| Arm/Group Title | Low Dose Asenapine Maleate Patch | High Dose Asenapine Maleate Patch | Placebo Patch | Total |
|---|---|---|---|---|
| Arm/Group Description | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. | High dose asenapine maleate, transdermal patches will be compared against placebo patches. High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. | Placebo transdermal patch | Total of all reporting groups |
| Overall Participants | 204 | 206 | 206 | 616 |
| Age, Customized (Count of Participants) | ||||
| <55 |
168
82.4%
|
172
83.5%
|
171
83%
|
511
83%
|
| >=55 |
36
17.6%
|
34
16.5%
|
35
17%
|
105
17%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
73
35.8%
|
95
46.1%
|
75
36.4%
|
243
39.4%
|
| Male |
131
64.2%
|
111
53.9%
|
131
63.6%
|
373
60.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
10
4.9%
|
5
2.4%
|
1
0.5%
|
16
2.6%
|
| Not Hispanic or Latino |
194
95.1%
|
201
97.6%
|
205
99.5%
|
600
97.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
1
0.5%
|
0
0%
|
1
0.2%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
47
23%
|
45
21.8%
|
54
26.2%
|
146
23.7%
|
| White |
157
77%
|
159
77.2%
|
152
73.8%
|
468
76%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
1
0.5%
|
0
0%
|
1
0.2%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
61
29.9%
|
62
30.1%
|
62
30.1%
|
185
30%
|
| Russia |
60
29.4%
|
60
29.1%
|
60
29.1%
|
180
29.2%
|
| Bulgaria |
29
14.2%
|
30
14.6%
|
29
14.1%
|
88
14.3%
|
| Ukraine |
35
17.2%
|
35
17%
|
36
17.5%
|
106
17.2%
|
| Serbia |
19
9.3%
|
19
9.2%
|
19
9.2%
|
57
9.3%
|
| Height (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
172.5
(9.08)
|
171.8
(9.09)
|
171.8
(9.16)
|
172.0
(9.10)
|
| BMI (kg/m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m^2] |
26.591
(5.1151)
|
26.240
(4.7834)
|
25.925
(4.8602)
|
26.251
(4.9205)
|
| PANSS total score (Count of Participants) | ||||
| <90 |
45
22.1%
|
53
25.7%
|
54
26.2%
|
152
24.7%
|
| >=90 |
159
77.9%
|
151
73.3%
|
152
73.8%
|
462
75%
|
Outcome Measures
| Title | Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Syndrome Scale (PANSS) Total Score: Change From Baseline to Week 6. |
|---|---|
| Description | To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by Positive and Negative Syndrome Scale (PANSS) total score. The PANSS total score is the sum of all 30 items (7 positive items, 7 negative items, and 16 general psychopathology items). For each item, severity was rated on an anchored 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. If one or more items are missing at a given assessment, the total score is set to missing. Total score ranges from 30 to 210. Score indicates severity of the disease, i.e. low score = low severity. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Results are from the full analysis set (FAS) which includes all randomized participants who had at least 1 patch of double-blind study medication applied and who have a baseline PANSS total score and at least 1 post baseline assessment of the primary efficacy measure (PANSS total score) and completed the study. |
| Arm/Group Title | Low Dose Asenapine Maleate Patch | High Dose Asenapine Maleate Patch | Placebo Patch |
|---|---|---|---|
| Arm/Group Description | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. | High dose asenapine maleate, transdermal patches will be compared against placebo patches. High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. | Placebo transdermal patch |
| Measure Participants | 201 | 203 | 203 |
| Least Squares Mean (Standard Error) [score on a scale] |
-22.1
(1.158)
|
-20.4
(1.162)
|
-15.5
(1.166)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | High Dose Asenapine Maleate Patch, Placebo Patch |
|---|---|---|
| Comments | The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom. | |
| Type of Statistical Test | Superiority | |
| Comments | Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison. | |
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | -4.8 | |
| Confidence Interval |
(2-Sided) 95% -8.06 to -1.64 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.634 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Low Dose Asenapine Maleate Patch, Placebo Patch |
|---|---|---|
| Comments | The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom. | |
| Type of Statistical Test | Superiority | |
| Comments | Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison. | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | -6.6 | |
| Confidence Interval |
(2-Sided) 95% -9.81 to -3.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.63 |
|
| Estimation Comments | ||
| Title | Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Clinical Global Impression - Severity of Illness Scale: Change From Baseline to Week 6. |
|---|---|
| Description | To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by the Clinical Global Impression - Severity of Illness Scale. The severity of illness for each participant was rated using the CGI-S. The rater or Investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?". Response choices included: 0 = not assessed; 1 = normal, not at all ill, 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Results are from the full analysis set (FAS) which includes all randomized participants who had at least 1 patch of double-blind study medication applied and who have a baseline PANSS total score and at least 1 post baseline assessment of the primary efficacy measure (PANSS total score) and completed the study. |
| Arm/Group Title | Low Dose Asenapine Maleate Patch | High Dose Asenapine Maleate Patch | Placebo Patch |
|---|---|---|---|
| Arm/Group Description | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. | High dose asenapine maleate, transdermal patches will be compared against placebo patches. High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. | Placebo transdermal patch |
| Measure Participants | 201 | 203 | 203 |
| Least Squares Mean (Standard Deviation) [score on a scale] |
-1.3
(0.90)
|
-1.2
(0.96)
|
-0.9
(0.93)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | High Dose Asenapine Maleate Patch, Placebo Patch |
|---|---|---|
| Comments | The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | -0.4 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to -0.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.1 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Low Dose Asenapine Maleate Patch, Placebo Patch |
|---|---|---|
| Comments | The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | -0.4 | |
| Confidence Interval |
(2-Sided) 95% -0.64 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.099 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period. | |||||
| Arm/Group Title | Low Dose Asenapine Maleate Patch | High Dose Asenapine Maleate Patch | Placebo | |||
| Arm/Group Description | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. | High dose asenapine maleate, transdermal patches will be compared against placebo patches. High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. | Placebo transdermal patch | |||
All Cause Mortality |
||||||
| Low Dose Asenapine Maleate Patch | High Dose Asenapine Maleate Patch | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/204 (0%) | 0/204 (0%) | 0/206 (0%) | |||
Serious Adverse Events |
||||||
| Low Dose Asenapine Maleate Patch | High Dose Asenapine Maleate Patch | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/204 (1.5%) | 2/204 (1%) | 4/206 (1.9%) | |||
| Cardiac disorders | ||||||
| Acute Coronary Syndrome | 1/204 (0.5%) | 1 | 0/204 (0%) | 0 | 0/206 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Gastrointestinal ulcer hemorrhage | 0/204 (0%) | 0 | 1/204 (0.5%) | 1 | 0/206 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Contusion | 0/204 (0%) | 0 | 0/204 (0%) | 0 | 1/206 (0.5%) | 1 |
| Overdose | 0/204 (0%) | 0 | 0/204 (0%) | 0 | 1/206 (0.5%) | 1 |
| Psychiatric disorders | ||||||
| Schizophrenia | 2/204 (1%) | 2 | 1/204 (0.5%) | 1 | 2/206 (1%) | 2 |
Other (Not Including Serious) Adverse Events |
||||||
| Low Dose Asenapine Maleate Patch | High Dose Asenapine Maleate Patch | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 75/204 (36.8%) | 78/204 (38.2%) | 70/206 (34%) | |||
| Gastrointestinal disorders | ||||||
| Constipation | 11/204 (5.4%) | 12 | 9/204 (4.4%) | 11 | 9/206 (4.4%) | 10 |
| General disorders | ||||||
| Application site erythema | 19/204 (9.3%) | 105 | 20/204 (9.8%) | 57 | 3/206 (1.5%) | 14 |
| Investigations | ||||||
| Weight increased | 8/204 (3.9%) | 8 | 12/204 (5.9%) | 12 | 4/206 (1.9%) | 4 |
| Nervous system disorders | ||||||
| Headache | 18/204 (8.8%) | 23 | 19/204 (9.3%) | 21 | 13/206 (6.3%) | 13 |
| Extrapyramidal disorder | 13/204 (6.4%) | 16 | 19/204 (9.3%) | 22 | 3/206 (1.5%) | 4 |
| Psychiatric disorders | ||||||
| Insomnia | 15/204 (7.4%) | 21 | 14/204 (6.9%) | 16 | 23/206 (11.2%) | 28 |
| Anxiety | 10/204 (4.9%) | 14 | 11/204 (5.4%) | 13 | 13/206 (6.3%) | 19 |
| Agitation | 5/204 (2.5%) | 5 | 6/204 (2.9%) | 7 | 11/206 (5.3%) | 14 |
Limitations/Caveats
[Not Specified]
More Information
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.
Results Point of Contact
| Name/Title | George Harb, MD, MPH - Executive Director, Clinical Development |
|---|---|
| Organization | Noven Pharmaceuticals |
| Phone | 1-551-233-2656 |
| gharb@noven.com |
Responsible Party:
Noven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02876900
Other Study ID Numbers:
- HP-3070-GL-04
First Posted:
Aug 24, 2016
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020