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Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00490945
Recruitment Status : Completed
First Posted : June 25, 2007
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Information provided by:
Vanda Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Circadian Rhythm Sleep Disorders
Intervention Drug: VEC-162
Enrollment 45
Recruitment Details  
Pre-assignment Details Number of Enrolled Subjects = 45 Number of Enrollment Failures = 6
Arm/Group Title Placebo 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Hide Arm/Group Description Randomized to Placebo Randomized to 10 mg VEC-162 Randomized to 20 mg VEC-162 Randomized to 50 mg VEC-162 Randomized to 100 mg VEC-162
Period Title: Overall Study
Started 8 9 8 7 7
Completed 8 8 8 7 7
Not Completed 0 1 0 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0
Arm/Group Title Placebo 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162 Total
Hide Arm/Group Description Randomized to Placebo Randomized to 10 mg VEC-162 Randomized to 20 mg VEC-162 Randomized to 50 mg VEC-162 Randomized to 100 mg VEC-162 Total of all reporting groups
Overall Number of Baseline Participants 8 9 8 7 7 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 8 participants 7 participants 7 participants 39 participants
27.5  (6.7) 31.8  (7.4) 32.5  (9.6) 27.4  (6.2) 30.4  (9.5) 30.0  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 8 participants 7 participants 7 participants 39 participants
Female
5
  62.5%
3
  33.3%
4
  50.0%
4
  57.1%
4
  57.1%
20
  51.3%
Male
3
  37.5%
6
  66.7%
4
  50.0%
3
  42.9%
3
  42.9%
19
  48.7%
1.Primary Outcome
Title Circadian Phase Shift
Hide Description Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.
Time Frame Night 3 and Night 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Hide Arm/Group Description:
Randomized to Placebo
Randomized to 10 mg VEC-162
Randomized to 20 mg VEC-162
Randomized to 50 mg VEC-162
Randomized to 100 mg VEC-162
Overall Number of Participants Analyzed 6 8 7 4 5
Mean (Standard Deviation)
Unit of Measure: Hours
-0.48  (0.84) 0.18  (2.48) -1.14  (0.46) -0.50  (0.32) -2.74  (1.95)
2.Primary Outcome
Title Mean Sleep Efficiency
Hide Description Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.
Time Frame Night 4 and Night 2
Hide Outcome Measure Data
Hide Analysis Population Description

*N = 6 for 3rd Third of Night Efficiency and N=8 for 1st Third of Night Efficiency

**N = 7 for 3rd Third of Night Efficiency

Arm/Group Title Placebo* 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Hide Arm/Group Description:
Randomized to Placebo
Randomized to 10 mg VEC-162**
Randomized to 20 mg VEC-162
Randomized to 50 mg VEC-162
Randomized to 100 mg VEC-162
Overall Number of Participants Analyzed 7 8 8 7 7
Mean (Standard Deviation)
Unit of Measure: % points
Full Night (% points) -20.27  (18.72) -7.77  (14.98) -6.68  (12.69) -5.87  (9.89) -2.02  (4.94)
1st Third of the Night (% points) -12.30  (14.51) -0.47  (12.39) -7.81  (14.52) 0.95  (7.79) -5.63  (17.71)
2nd Third of the Night (% points) -34.92  (38.23) -12.64  (13.83) -5.11  (12.78) -2.10  (4.14) -2.30  (5.72)
3rd Third of the NIght (% points) -8.06  (29.69) -10.51  (35.17) -7.09  (26.24) -16.48  (26.25) 1.80  (14.15)
3.Secondary Outcome
Title Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)
Hide Description

Wake After Sleep Onset is defined as the total time that is scored as awake in a PSG occurring between sleep onset and lights-on prompt.

Latency to Persistent Sleep is defined as the number of epochs (one 30-second interval of the sleep episode) from the beginning of the recording (lights-out) to the start of persistent sleep (first 20 consecutive non-wake state) divided by 2.

Time Frame Night 2 and Night 4
Hide Outcome Measure Data
Hide Analysis Population Description
*Placebo N = 7 and 100 mg VEC-162 N = 7
Arm/Group Title Placebo 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Hide Arm/Group Description:
Randomized to Placebo
Randomized to 10 mg VEC-162
Randomized to 20 mg VEC-162
Randomized to 50 mg VEC-162
Randomized to 100 mg VEC-162
Overall Number of Participants Analyzed 8 8 8 7 6
Mean (Standard Deviation)
Unit of Measure: minutes
Latency to Persistent Sleep 15.13  (21.25) -8.25  (16.34) 5.00  (11.89) -3.71  (10.97) -4.17  (6.93)
WASO* 77.00  (91.01) 40.56  (67.53) 31.19  (53.80) 31.21  (52.69) 8.50  (20.39)
4.Secondary Outcome
Title VEC-162 AUC
Hide Description [Not Specified]
Time Frame Night 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Hide Arm/Group Description:
Randomized to 10 mg VEC-162
Randomized to 20 mg VEC-162
Randomized to 50 mg VEC-162
Randomized to 100 mg VEC-162
Overall Number of Participants Analyzed 9 8 7 7
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
171.73  (118.51) 482.00  (329.48) 614.34  (488.08) 1916.06  (601.35)
5.Secondary Outcome
Title VEC-162 Cmax
Hide Description [Not Specified]
Time Frame Night 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Hide Arm/Group Description:
Randomized to 10 mg VEC-162
Randomized to 20 mg VEC-162
Randomized to 50 mg VEC-162
Randomized to 100 mg VEC-162
Overall Number of Participants Analyzed 9 8 7 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
59.10  (39.22) 139.94  (116.10) 166.01  (164.94) 417.80  (187.19)
6.Secondary Outcome
Title VEC-162 Tmax
Hide Description [Not Specified]
Time Frame Night 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Hide Arm/Group Description:
Randomized to 10 mg VEC-162
Randomized to 20 mg VEC-162
Randomized to 50 mg VEC-162
Randomized to 100 mg VEC-162
Overall Number of Participants Analyzed 9 8 7 7
Mean (Standard Deviation)
Unit of Measure: hour
1.90  (1.78) 2.04  (0.90) 2.42  (0.59) 3.03  (1.50)
Time Frame 1st dose to 30 days following last administration of study treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Hide Arm/Group Description Randomized to Placebo Randomized to 10 mg VEC-162 Randomized to 20 mg VEC-162 Randomized to 50 mg VEC-162 Randomized to 100 mg VEC-162
All-Cause Mortality
Placebo 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/9 (0.00%)      0/8 (0.00%)      0/7 (0.00%)      0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 10 mg VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg VEC-162
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      8/9 (88.89%)      7/8 (87.50%)      7/7 (100.00%)      7/7 (100.00%)    
Blood and lymphatic system disorders           
Anaemia  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Eosinophilia  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Eye disorders           
Conjunctival Hyperaemia  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Gastrointestinal disorders           
Abdominal Pain  1  0/8 (0.00%)  0 2/9 (22.22%)  2 0/8 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1
Nausea  1  2/8 (25.00%)  3 1/9 (11.11%)  1 0/8 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Abdominal Pain Upper  1  0/8 (0.00%)  0 0/9 (0.00%)  0 2/8 (25.00%)  2 1/7 (14.29%)  1 0/7 (0.00%)  0
Constipation  1  0/8 (0.00%)  0 0/9 (0.00%)  0 2/8 (25.00%)  3 0/7 (0.00%)  0 1/7 (14.29%)  1
Diarrhoea  1  0/8 (0.00%)  0 2/9 (22.22%)  2 0/8 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Vomiting  1  0/8 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Abdominal Tenderness  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Dry Mouth  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
General disorders           
Application Site Irritation  1  3/8 (37.50%)  3 1/9 (11.11%)  1 2/8 (25.00%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0
Injection Site Pain  1  1/8 (12.50%)  1 1/9 (11.11%)  1 1/8 (12.50%)  1 2/7 (28.57%)  2 1/7 (14.29%)  1
Injection Site Bruising  1  1/8 (12.50%)  1 1/9 (11.11%)  1 2/8 (25.00%)  2 1/7 (14.29%)  1 0/7 (0.00%)  0
Application Site Pain  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 2/7 (28.57%)  3 1/7 (14.29%)  1
Feeling Hot  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 1/7 (14.29%)  1
Application Site Reaction  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  2 0/7 (0.00%)  0
Asthenia  1  1/8 (12.50%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Fatigue  1  1/8 (12.50%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Chest Pain  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Injection Site Anaesthesia  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Injection Site Burning  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Injection Site Discomfort  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Injection Site Erythema  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Injection Site Irritation  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Injection Site Movement Impairment  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Pain  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations           
Herpes Simplex  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Investigations           
Haematocrit Decreased  1  3/8 (37.50%)  3 4/9 (44.44%)  4 3/8 (37.50%)  3 4/7 (57.14%)  4 4/7 (57.14%)  4
Haemoglobin Decreased  1  2/8 (25.00%)  2 3/9 (33.33%)  3 0/8 (0.00%)  0 2/7 (28.57%)  2 3/7 (42.86%)  3
Blood Pressure Systolic Decreased  1  0/8 (0.00%)  0 2/9 (22.22%)  2 1/8 (12.50%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0
White Blood Cell Count Decreased  1  1/8 (12.50%)  1 2/9 (22.22%)  2 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Blood Pressure Diastolic Decreased  1  0/8 (0.00%)  0 2/9 (22.22%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Blood Pressure Diastolic Increased  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1
Neutrophil Count Decreased  1  0/8 (0.00%)  0 2/9 (22.22%)  4 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Alanine Aminotransferase Increased  1  0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Blood Phosphorus Increased  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Blood Potassium Increased  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Blood Pressure Systolic Increased  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  2 0/7 (0.00%)  0
Electrocardiogram Abnormal  1  0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Eosinophil Count Increased  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Heart Rate Decreased  1  0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Heart Rate Increased  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  2 0/7 (0.00%)  0
Lymphocyte Count Increased  1  0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Monocyte Count Decreased  1  0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Platelet Count Decreased  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders           
Hyperkalaemia  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Hyperphosphataemia  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back Pain  1  0/8 (0.00%)  0 0/9 (0.00%)  0 2/8 (25.00%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0
Arthralgia  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Musculoskeletal Stiffness  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Neck Pain  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Pain in Extremity  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Nervous system disorders           
Somnolence  1  4/8 (50.00%)  7 3/9 (33.33%)  3 2/8 (25.00%)  3 5/7 (71.43%)  7 2/7 (28.57%)  2
Headache  1  2/8 (25.00%)  2 1/9 (11.11%)  1 1/8 (12.50%)  1 1/7 (14.29%)  1 2/7 (28.57%)  3
Dizziness  1  0/8 (0.00%)  0 2/9 (22.22%)  4 0/8 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  2
Syncope Vasovagal  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Psychiatric disorders           
Anxiety  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Insomnia  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1
Nervousness  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 2/7 (28.57%)  2 0/7 (0.00%)  0
Abnormal Dreams  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Mental Disorder  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Sleep Disorder  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Renal and urinary disorders           
Pollakiuria  1  0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Reproductive system and breast disorders           
Dysmenorrhoea  1  0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Vaginal Discharge  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Pharyngolaryngeal Pain  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Productive Cough  1  0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders           
Rash  1  0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Vascular disorders           
Hypotension  1  1/8 (12.50%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Marlene Dressman, Ph.D.
Organization: Vanda Pharmaceuticals Inc.
Phone: 202-734-3462
EMail: marelene.dressman@vandapharma.com
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ClinicalTrials.gov Identifier: NCT00490945    
Other Study ID Numbers: VP-VEC-162-2101
First Submitted: June 22, 2007
First Posted: June 25, 2007
Results First Submitted: February 28, 2014
Results First Posted: August 26, 2014
Last Update Posted: August 26, 2014