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A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer

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: NCT01424930
Recruitment Status : Completed
First Posted : August 29, 2011
Results First Posted : April 30, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen-Ortho Inc., Canada

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Neoplasms
Prostate Cancer
Interventions Drug: Abiraterone
Drug: Prednisone
Enrollment 25
Recruitment Details The study was conducted from 29 September 2011 to 29 May 2013. Participants were recruited at 2 study centers in Canada.
Pre-assignment Details  
Arm/Group Title Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal)
Hide Arm/Group Description Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14. Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
Period Title: Overall Study
Started 7 18
Completed Food Safety Evaluation 6 18
Completed 3 4
Not Completed 4 14
Reason Not Completed
Adverse Event             0             1
Death             1             0
Progressive Disease             3             6
Screen Failure             0             1
Reason not specified             0             6
Arm/Group Title Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal) Total
Hide Arm/Group Description Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14. Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14 Total of all reporting groups
Overall Number of Baseline Participants 7 18 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 18 participants 25 participants
75.1  (11.01) 69.1  (7.26) 70.8  (8.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 18 participants 25 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
7
 100.0%
18
 100.0%
25
 100.0%
1.Primary Outcome
Title Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication
Hide Description AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Time Frame Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: Participants who received at least 1 dose of study medication and contributed any safety data after the start of study treatment.
Arm/Group Title Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal)
Hide Arm/Group Description:
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
Overall Number of Participants Analyzed 6 18
Measure Type: Number
Unit of Measure: Participants
0 0
2.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Abiraterone
Hide Description The table below shows mean Cmax of Abiraterone. The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Time Frame Day 7 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.
Arm/Group Title Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal)
Hide Arm/Group Description:
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
Overall Number of Participants Analyzed 7 18
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 7 218  (168) 196  (234)
Day 14 265  (229) 342  (289)
3.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone
Hide Description The table below shows median Tmax of Abiraterone. The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time Frame Day 7 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.
Arm/Group Title Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal)
Hide Arm/Group Description:
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
Overall Number of Participants Analyzed 7 18
Median (Full Range)
Unit of Measure: hours
Day 7
2
(1.0 to 8.1)
2
(0.5 to 6.0)
Day 14
2.5
(1.0 to 3.0)
4.0
(3.0 to 10.0)
4.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
Hide Description The table below shows mean AUC24h. The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Time Frame Day 7 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.
Arm/Group Title Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal)
Hide Arm/Group Description:
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
Overall Number of Participants Analyzed 7 18
Geometric Mean (Standard Deviation)
Unit of Measure: ng*h/mL
Day 7 1271  (1279) 973  (667)
Day 14 1264  (963) 1992  (720)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal)
Hide Arm/Group Description Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14. Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
All-Cause Mortality
Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/7 (57.14%)   4/18 (22.22%) 
Cardiac disorders     
Myocardial Infarction * 1  1/7 (14.29%)  0/18 (0.00%) 
Gastrointestinal disorders     
Small Intestinal Obstruction * 1  0/7 (0.00%)  1/18 (5.56%) 
Vomiting * 1  1/7 (14.29%)  0/18 (0.00%) 
General disorders     
Fatigue * 1  0/7 (0.00%)  1/18 (5.56%) 
Pyrexia * 1  0/7 (0.00%)  1/18 (5.56%) 
Infections and infestations     
Gastroenteritis * 1  0/7 (0.00%)  1/18 (5.56%) 
Lobar Pneumonia * 1  1/7 (14.29%)  0/18 (0.00%) 
Pneumonia * 1  1/7 (14.29%)  1/18 (5.56%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/7 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/7 (14.29%)  0/18 (0.00%) 
Bone Pain * 1  1/7 (14.29%)  0/18 (0.00%) 
Muscular Weakness * 1  1/7 (14.29%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile Duct Cancer * 1  0/7 (0.00%)  1/18 (5.56%) 
Colorectal Cancer * 1  0/7 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
Spinal Cord Compression * 1  0/7 (0.00%)  1/18 (5.56%) 
Syncope * 1  0/7 (0.00%)  1/18 (5.56%) 
Psychiatric disorders     
Confusional State * 1  0/7 (0.00%)  1/18 (5.56%) 
Delirium * 1  1/7 (14.29%)  1/18 (5.56%) 
Vascular disorders     
Hypotension * 1  0/7 (0.00%)  1/18 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abiraterone+Prednisone (Low-fat Meal) Abiraterone+Prednisone (High-fat Meal)
Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   18/18 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/7 (0.00%)  1/18 (5.56%) 
Ear and labyrinth disorders     
Ear Discomfort * 1  1/7 (14.29%)  0/18 (0.00%) 
Endocrine disorders     
Cushingoid * 1  1/7 (14.29%)  0/18 (0.00%) 
Eye disorders     
Blepharospasm * 1  0/7 (0.00%)  1/18 (5.56%) 
Blindness Transient * 1  0/7 (0.00%)  1/18 (5.56%) 
Eye Swelling * 1  1/7 (14.29%)  1/18 (5.56%) 
Ocular Hyperaemia * 1  0/7 (0.00%)  1/18 (5.56%) 
Vision Blurred * 1  1/7 (14.29%)  0/18 (0.00%) 
Visual Impairment * 1  0/7 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Abdominal Discomfort * 1  0/7 (0.00%)  1/18 (5.56%) 
Abdominal Distension * 1  0/7 (0.00%)  1/18 (5.56%) 
Abdominal Pain * 1  1/7 (14.29%)  4/18 (22.22%) 
Constipation * 1  4/7 (57.14%)  7/18 (38.89%) 
Diarrhoea * 1  4/7 (57.14%)  6/18 (33.33%) 
Dry Mouth * 1  1/7 (14.29%)  2/18 (11.11%) 
Faecal Incontinence * 1  0/7 (0.00%)  1/18 (5.56%) 
Gastritis * 1  0/7 (0.00%)  1/18 (5.56%) 
Haematochezia * 1  0/7 (0.00%)  2/18 (11.11%) 
Lower Gastrointestinal Haemorrhage * 1  0/7 (0.00%)  1/18 (5.56%) 
Nausea * 1  4/7 (57.14%)  7/18 (38.89%) 
Oral Discharge * 1  1/7 (14.29%)  0/18 (0.00%) 
Oral Pain * 1  0/7 (0.00%)  1/18 (5.56%) 
Stomatitis * 1  0/7 (0.00%)  2/18 (11.11%) 
Vomiting * 1  3/7 (42.86%)  4/18 (22.22%) 
General disorders     
Chills * 1  1/7 (14.29%)  1/18 (5.56%) 
Facial Pain * 1  1/7 (14.29%)  0/18 (0.00%) 
Fatigue * 1  3/7 (42.86%)  11/18 (61.11%) 
Gait Disturbance * 1  0/7 (0.00%)  1/18 (5.56%) 
Non-Cardiac Chest Pain * 1  1/7 (14.29%)  3/18 (16.67%) 
Oedema Peripheral * 1  4/7 (57.14%)  6/18 (33.33%) 
Pyrexia * 1  0/7 (0.00%)  2/18 (11.11%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  1/7 (14.29%)  1/18 (5.56%) 
Immune system disorders     
Hypersensitivity * 1  1/7 (14.29%)  1/18 (5.56%) 
Infections and infestations     
Cystitis * 1  0/7 (0.00%)  3/18 (16.67%) 
Gastroenteritis Viral * 1  1/7 (14.29%)  1/18 (5.56%) 
Herpes Zoster * 1  1/7 (14.29%)  1/18 (5.56%) 
Influenza * 1  0/7 (0.00%)  1/18 (5.56%) 
Nasopharyngitis * 1  1/7 (14.29%)  1/18 (5.56%) 
Oral Herpes * 1  0/7 (0.00%)  1/18 (5.56%) 
Pharyngitis * 1  1/7 (14.29%)  0/18 (0.00%) 
Urinary Tract Infection * 1  0/7 (0.00%)  3/18 (16.67%) 
Injury, poisoning and procedural complications     
Contusion * 1  2/7 (28.57%)  0/18 (0.00%) 
Excoriation * 1  1/7 (14.29%)  0/18 (0.00%) 
Fall * 1  0/7 (0.00%)  1/18 (5.56%) 
Gastrointestinal Stoma Complication * 1  0/7 (0.00%)  1/18 (5.56%) 
Laceration * 1  0/7 (0.00%)  1/18 (5.56%) 
Rib Fracture * 1  0/7 (0.00%)  1/18 (5.56%) 
Investigations     
Alanine Aminotransferase Increased * 1  0/7 (0.00%)  1/18 (5.56%) 
Aspartate Aminotransferase Increased * 1  0/7 (0.00%)  1/18 (5.56%) 
Blood Alkaline Phosphatase Increased * 1  0/7 (0.00%)  1/18 (5.56%) 
Platelet Count Decreased * 1  1/7 (14.29%)  0/18 (0.00%) 
Weight Decreased * 1  1/7 (14.29%)  0/18 (0.00%) 
Weight Increased * 1  1/7 (14.29%)  2/18 (11.11%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  4/7 (57.14%)  8/18 (44.44%) 
Dehydration * 1  1/7 (14.29%)  2/18 (11.11%) 
Hyperglycaemia * 1  0/7 (0.00%)  1/18 (5.56%) 
Hyperkalaemia * 1  0/7 (0.00%)  1/18 (5.56%) 
Hypocalcaemia * 1  0/7 (0.00%)  1/18 (5.56%) 
Hypoglycaemia * 1  1/7 (14.29%)  0/18 (0.00%) 
Hypokalaemia * 1  5/7 (71.43%)  7/18 (38.89%) 
Hypomagnesaemia * 1  1/7 (14.29%)  0/18 (0.00%) 
Hypophosphataemia * 1  2/7 (28.57%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/7 (42.86%)  8/18 (44.44%) 
Back Pain * 1  4/7 (57.14%)  7/18 (38.89%) 
Bone Pain * 1  4/7 (57.14%)  2/18 (11.11%) 
Bursitis * 1  0/7 (0.00%)  1/18 (5.56%) 
Coccydynia * 1  0/7 (0.00%)  1/18 (5.56%) 
Exostosis of Jaw * 1  0/7 (0.00%)  1/18 (5.56%) 
Flank Pain * 1  0/7 (0.00%)  2/18 (11.11%) 
Groin Pain * 1  0/7 (0.00%)  1/18 (5.56%) 
Muscle Spasms * 1  1/7 (14.29%)  4/18 (22.22%) 
Muscle Twitching * 1  0/7 (0.00%)  1/18 (5.56%) 
Muscular Weakness * 1  1/7 (14.29%)  2/18 (11.11%) 
Musculoskeletal Pain * 1  3/7 (42.86%)  1/18 (5.56%) 
Musculoskeletal Stiffness * 1  0/7 (0.00%)  1/18 (5.56%) 
Pain in Extremity * 1  0/7 (0.00%)  4/18 (22.22%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma * 1  1/7 (14.29%)  0/18 (0.00%) 
Nervous system disorders     
Depressed Level of Consciousness * 1  1/7 (14.29%)  1/18 (5.56%) 
Disturbance in Attention * 1  0/7 (0.00%)  1/18 (5.56%) 
Dizziness * 1  2/7 (28.57%)  2/18 (11.11%) 
Headache * 1  0/7 (0.00%)  5/18 (27.78%) 
Hypoaesthesia * 1  1/7 (14.29%)  1/18 (5.56%) 
Myoclonus * 1  0/7 (0.00%)  1/18 (5.56%) 
Neuropathy Peripheral * 1  1/7 (14.29%)  3/18 (16.67%) 
Paraesthesia * 1  2/7 (28.57%)  2/18 (11.11%) 
Peripheral Motor Neuropathy * 1  0/7 (0.00%)  1/18 (5.56%) 
Peripheral Sensory Neuropathy * 1  1/7 (14.29%)  1/18 (5.56%) 
Sinus Headache * 1  0/7 (0.00%)  1/18 (5.56%) 
Somnolence * 1  0/7 (0.00%)  2/18 (11.11%) 
Syncope * 1  0/7 (0.00%)  1/18 (5.56%) 
Psychiatric disorders     
"hallucination * 1  0/7 (0.00%)  1/18 (5.56%) 
Abnormal Dreams * 1  0/7 (0.00%)  1/18 (5.56%) 
Anxiety * 1  2/7 (28.57%)  1/18 (5.56%) 
Confusional State * 1  0/7 (0.00%)  1/18 (5.56%) 
Delirium * 1  1/7 (14.29%)  1/18 (5.56%) 
Depression * 1  1/7 (14.29%)  1/18 (5.56%) 
Insomnia * 1  1/7 (14.29%)  2/18 (11.11%) 
Mental Disorder * 1  0/7 (0.00%)  1/18 (5.56%) 
Renal and urinary disorders     
Bladder Spasm * 1  0/7 (0.00%)  1/18 (5.56%) 
Dysuria * 1  0/7 (0.00%)  2/18 (11.11%) 
Haematuria * 1  1/7 (14.29%)  0/18 (0.00%) 
Loss of Bladder Sensation * 1  0/7 (0.00%)  1/18 (5.56%) 
Nephrolithiasis * 1  0/7 (0.00%)  1/18 (5.56%) 
Pollakiuria * 1  1/7 (14.29%)  2/18 (11.11%) 
Urinary Hesitation * 1  0/7 (0.00%)  1/18 (5.56%) 
Urinary Incontinence * 1  2/7 (28.57%)  0/18 (0.00%) 
Urinary Retention * 1  0/7 (0.00%)  2/18 (11.11%) 
Reproductive system and breast disorders     
Breast Pain * 1  0/7 (0.00%)  1/18 (5.56%) 
Gynaecomastia * 1  0/7 (0.00%)  2/18 (11.11%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/7 (28.57%)  4/18 (22.22%) 
Dyspnoea * 1  1/7 (14.29%)  2/18 (11.11%) 
Dyspnoea Exertional * 1  0/7 (0.00%)  2/18 (11.11%) 
Nasal Congestion * 1  1/7 (14.29%)  1/18 (5.56%) 
Oropharyngeal Pain * 1  0/7 (0.00%)  1/18 (5.56%) 
Pleural Effusion * 1  0/7 (0.00%)  1/18 (5.56%) 
Rhinorrhoea * 1  0/7 (0.00%)  1/18 (5.56%) 
Wheezing * 1  0/7 (0.00%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  1/7 (14.29%)  0/18 (0.00%) 
Dry Skin * 1  1/7 (14.29%)  3/18 (16.67%) 
Nail Disorder * 1  1/7 (14.29%)  0/18 (0.00%) 
Night Sweats * 1  0/7 (0.00%)  1/18 (5.56%) 
Pruritus * 1  1/7 (14.29%)  2/18 (11.11%) 
Purpura * 1  0/7 (0.00%)  1/18 (5.56%) 
Rash * 1  1/7 (14.29%)  1/18 (5.56%) 
Rash Erythematous * 1  1/7 (14.29%)  0/18 (0.00%) 
Skin Atrophy * 1  1/7 (14.29%)  0/18 (0.00%) 
Swelling Face * 1  0/7 (0.00%)  1/18 (5.56%) 
Vascular disorders     
Hot Flush * 1  2/7 (28.57%)  5/18 (27.78%) 
Hypertension * 1  1/7 (14.29%)  2/18 (11.11%) 
Hypotension * 1  0/7 (0.00%)  2/18 (11.11%) 
Peripheral Coldness * 1  1/7 (14.29%)  0/18 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
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
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen R&D US
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier: NCT01424930     History of Changes
Other Study ID Numbers: CR018715
212082PCR2008 ( Other Identifier: Janssen-Ortho, Canada )
First Submitted: August 26, 2011
First Posted: August 29, 2011
Results First Submitted: March 28, 2014
Results First Posted: April 30, 2014
Last Update Posted: July 25, 2014