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Trial record 9 of 102 for:    Valcyte

IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients (IMPACT)

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: NCT00294515
Recruitment Status : Completed
First Posted : February 22, 2006
Results First Posted : July 5, 2010
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cytomegalovirus Infections
Intervention Drug: Valganciclovir
Enrollment 326
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Hide Arm/Group Description 900 mg valganciclovir orally daily for up to 100 days 900 mg valganciclovir orally daily for up to 200 days
Period Title: Overall Study
Started 166 [1] 160 [1]
Completed 132 132
Not Completed 34 28
[1]
Randomized
Arm/Group Title Valganciclovir up to 100 Days Valganciclovir up to 200 Days Total
Hide Arm/Group Description 900 mg valganciclovir orally daily for up to 100 days 900 mg valganciclovir orally daily for up to 200 days Total of all reporting groups
Overall Number of Baseline Participants 164 156 320
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 156 participants 320 participants
48.5  (13.76) 47.0  (13.51) 47.8  (13.64)
[1]
Measure Description: Safety population
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 156 participants 320 participants
Female
45
  27.4%
40
  25.6%
85
  26.6%
Male
119
  72.6%
116
  74.4%
235
  73.4%
[1]
Measure Description: Safety population
1.Primary Outcome
Title Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant
Hide Description Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.
Time Frame 12 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Hide Arm/Group Description:
900 mg valganciclovir orally daily for up to 100 days
900 mg valganciclovir orally daily for up to 200 days
Overall Number of Participants Analyzed 163 155
Mean (95% Confidence Interval)
Unit of Measure: Percentage of patients
43.6
(35.8 to 51.5)
23.9
(17.4 to 31.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valganciclovir up to 100 Days, Valganciclovir up to 200 Days
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <=0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Center Pools
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.25 to 0.66
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant
Hide Description Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.
Time Frame 6 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Hide Arm/Group Description:
900 mg valganciclovir orally daily for up to 100 days
900 mg valganciclovir orally daily for up to 200 days
Overall Number of Participants Analyzed 163 155
Mean (95% Confidence Interval)
Unit of Measure: Percentage of patients
36.2
(28.8 to 44.1)
10.3
(6.0 to 16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valganciclovir up to 100 Days, Valganciclovir up to 200 Days
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Center Pools
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.20
Confidence Interval 95%
0.11 to 0.37
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant
Hide Description Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant.
Time Frame 9 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Hide Arm/Group Description:
900 mg valganciclovir orally daily for up to 100 days
900 mg valganciclovir orally daily for up to 200 days
Overall Number of Participants Analyzed 163 155
Mean (95% Confidence Interval)
Unit of Measure: Percentage of patients
43.6
(35.8 to 51.5)
22.6
(16.3 to 30.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valganciclovir up to 100 Days, Valganciclovir up to 200 Days
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Center Pools
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.37
Confidence Interval 95%
0.22 to 0.60
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant
Hide Description Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant.
Time Frame 18 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Hide Arm/Group Description:
900 mg valganciclovir orally daily for up to 100 days
900 mg valganciclovir orally daily for up to 200 days
Overall Number of Participants Analyzed 163 155
Mean (95% Confidence Interval)
Unit of Measure: Percentage of patients
47.9
(40.0 to 55.8)
34.2
(26.8 to 42.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valganciclovir up to 100 Days, Valganciclovir up to 200 Days
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0126
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Center Pools
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.56
Confidence Interval 95%
0.35 to 0.88
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
Hide Description Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant.
Time Frame 24 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Hide Arm/Group Description:
900 mg valganciclovir orally daily for up to 100 days
900 mg valganciclovir orally daily for up to 200 days
Overall Number of Participants Analyzed 163 155
Mean (95% Confidence Interval)
Unit of Measure: Percentage of patients
48.5
(40.6 to 56.4)
34.2
(26.8 to 42.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valganciclovir up to 100 Days, Valganciclovir up to 200 Days
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0100
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Center Pools
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.55
Confidence Interval 95%
0.34 to 0.86
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population
 
Arm/Group Title Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Hide Arm/Group Description 900 mg valganciclovir orally daily for up to 100 days 900 mg valganciclovir orally daily for up to 200 days
All-Cause Mortality
Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Affected / at Risk (%) Affected / at Risk (%)
Total   94/164 (57.32%)   78/156 (50.00%) 
Blood and lymphatic system disorders     
Neutropenia  3/164 (1.83%)  9/156 (5.77%) 
Febrile Neutropenia  1/164 (0.61%)  2/156 (1.28%) 
Leukopenia  2/164 (1.22%)  1/156 (0.64%) 
Agranulocytosis  1/164 (0.61%)  0/156 (0.00%) 
Anaemia  1/164 (0.61%)  0/156 (0.00%) 
Bicytopenia  0/164 (0.00%)  1/156 (0.64%) 
Haemolytic Anaemia  1/164 (0.61%)  0/156 (0.00%) 
Thrombocytopenia  0/164 (0.00%)  1/156 (0.64%) 
Cardiac disorders     
Acute Coronary Syndrome  0/164 (0.00%)  2/156 (1.28%) 
Arrhythmia  1/164 (0.61%)  1/156 (0.64%) 
Myocardial Infarction  0/164 (0.00%)  2/156 (1.28%) 
Angina Pectoris  0/164 (0.00%)  1/156 (0.64%) 
Arrhythmia Supraventricular  1/164 (0.61%)  0/156 (0.00%) 
Cardiac Failure  1/164 (0.61%)  0/156 (0.00%) 
Mitral Valve Disease  1/164 (0.61%)  0/156 (0.00%) 
Pericardial Effusion  1/164 (0.61%)  0/156 (0.00%) 
Tachycardia  1/164 (0.61%)  0/156 (0.00%) 
Congenital, familial and genetic disorders     
Hereditary Haemorrhagic Telangiectasia  0/164 (0.00%)  1/156 (0.64%) 
Renal Arteriovenous Malformation  0/164 (0.00%)  1/156 (0.64%) 
Endocrine disorders     
Hyperparathyroidism  1/164 (0.61%)  0/156 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  2/164 (1.22%)  4/156 (2.56%) 
Abdominal Pain  1/164 (0.61%)  3/156 (1.92%) 
Pancreatitis  2/164 (1.22%)  0/156 (0.00%) 
Abdominal Pain Upper  0/164 (0.00%)  1/156 (0.64%) 
Colitis  0/164 (0.00%)  1/156 (0.64%) 
Constipation  1/164 (0.61%)  0/156 (0.00%) 
Gastric Ulcer  0/164 (0.00%)  1/156 (0.64%) 
Gastrooesophageal Reflux Disease  0/164 (0.00%)  1/156 (0.64%) 
Impaired Gastric Emptying  0/164 (0.00%)  1/156 (0.64%) 
Inguinal Hernia  0/164 (0.00%)  1/156 (0.64%) 
Intestinal Ischaemia  1/164 (0.61%)  0/156 (0.00%) 
Large Intestine Perforation  0/164 (0.00%)  1/156 (0.64%) 
Mouth Ulceration  1/164 (0.61%)  0/156 (0.00%) 
Oral Pain  1/164 (0.61%)  0/156 (0.00%) 
Pancreatitis Acute  1/164 (0.61%)  0/156 (0.00%) 
Small Intestinal Obstruction  0/164 (0.00%)  1/156 (0.64%) 
General disorders     
Pyrexia  3/164 (1.83%)  4/156 (2.56%) 
Chest Pain  0/164 (0.00%)  2/156 (1.28%) 
Impaired Healing  0/164 (0.00%)  2/156 (1.28%) 
Malaise  0/164 (0.00%)  2/156 (1.28%) 
Asthenia  0/164 (0.00%)  1/156 (0.64%) 
Catheter Related Complication  0/164 (0.00%)  1/156 (0.64%) 
Catheter Site Discharge  1/164 (0.61%)  0/156 (0.00%) 
Multi-organ Failure  1/164 (0.61%)  0/156 (0.00%) 
Non-cardiac Chest Pain  0/164 (0.00%)  1/156 (0.64%) 
Oedema Peripheral  0/164 (0.00%)  1/156 (0.64%) 
Immune system disorders     
Transplant Rejection  11/164 (6.71%)  8/156 (5.13%) 
Kidney Transplant Rejection  3/164 (1.83%)  0/156 (0.00%) 
Food Allergy  1/164 (0.61%)  0/156 (0.00%) 
Infections and infestations     
Cytomegalovirus Infection  21/164 (12.80%)  5/156 (3.21%) 
Urinary Tract Infection  7/164 (4.27%)  10/156 (6.41%) 
Cytomegalovirus Syndrome  12/164 (7.32%)  1/156 (0.64%) 
Gastroenteritis  2/164 (1.22%)  3/156 (1.92%) 
Pyelonephritis Acute  2/164 (1.22%)  2/156 (1.28%) 
Sepsis  1/164 (0.61%)  3/156 (1.92%) 
Pneumonia  1/164 (0.61%)  2/156 (1.28%) 
Cytomegalovirus Viraemia  2/164 (1.22%)  0/156 (0.00%) 
Wound Infection  1/164 (0.61%)  1/156 (0.64%) 
Abscess Limb  0/164 (0.00%)  1/156 (0.64%) 
Bacterial Infection  1/164 (0.61%)  0/156 (0.00%) 
Bronchopneumonia  1/164 (0.61%)  0/156 (0.00%) 
Campylobacter Infection  1/164 (0.61%)  0/156 (0.00%) 
Cellulitis  1/164 (0.61%)  0/156 (0.00%) 
Cytomegalovirus Colitis  1/164 (0.61%)  0/156 (0.00%) 
Cytomegalovirus Hepatitis  1/164 (0.61%)  0/156 (0.00%) 
Erysipelas  0/164 (0.00%)  1/156 (0.64%) 
Escherichia Sepsis  0/164 (0.00%)  1/156 (0.64%) 
Escherichia Urinary Tract Infection  0/164 (0.00%)  1/156 (0.64%) 
Febrile Infection  0/164 (0.00%)  1/156 (0.64%) 
Folliculitis  1/164 (0.61%)  0/156 (0.00%) 
Klebsiella Infection  1/164 (0.61%)  0/156 (0.00%) 
Lung Infection Pseudomonal  0/164 (0.00%)  1/156 (0.64%) 
Mediastinitis  0/164 (0.00%)  1/156 (0.64%) 
Perirectal Abscess  1/164 (0.61%)  0/156 (0.00%) 
Pneumonia Streptococcal  1/164 (0.61%)  0/156 (0.00%) 
Pyelonephritis  0/164 (0.00%)  1/156 (0.64%) 
Septic Shock  1/164 (0.61%)  0/156 (0.00%) 
Subcutaneous Abscess  1/164 (0.61%)  0/156 (0.00%) 
Upper Respiratory Tract Infection  0/164 (0.00%)  1/156 (0.64%) 
Urosepsis  1/164 (0.61%)  0/156 (0.00%) 
Injury, poisoning and procedural complications     
Complications of Transplanted Kidney  2/164 (1.22%)  1/156 (0.64%) 
Graft Dysfunction  0/164 (0.00%)  2/156 (1.28%) 
Complications of Transplant Surgery  1/164 (0.61%)  0/156 (0.00%) 
Contusion  0/164 (0.00%)  1/156 (0.64%) 
Hip Fracture  1/164 (0.61%)  0/156 (0.00%) 
Medical Device Complication  0/164 (0.00%)  1/156 (0.64%) 
Overdose  1/164 (0.61%)  0/156 (0.00%) 
Post Procedural Fistula  1/164 (0.61%)  0/156 (0.00%) 
Ureteric Anastomosis Complication  0/164 (0.00%)  1/156 (0.64%) 
Wound Dehiscence  1/164 (0.61%)  0/156 (0.00%) 
Wound Secretion  0/164 (0.00%)  1/156 (0.64%) 
Investigations     
Blood Creatinine Increased  10/164 (6.10%)  8/156 (5.13%) 
Metabolism and nutrition disorders     
Dehydration  4/164 (2.44%)  1/156 (0.64%) 
Diabetes Mellitus  0/164 (0.00%)  2/156 (1.28%) 
Hyperkalaemia  1/164 (0.61%)  1/156 (0.64%) 
Diabetes Mellitus Inadequate Control  1/164 (0.61%)  0/156 (0.00%) 
Diabetic Ketoacidosis  1/164 (0.61%)  0/156 (0.00%) 
Hyperglycaemia  1/164 (0.61%)  0/156 (0.00%) 
Hypoglycaemia  0/164 (0.00%)  1/156 (0.64%) 
Hyponatraemia  0/164 (0.00%)  1/156 (0.64%) 
Musculoskeletal and connective tissue disorders     
Muscle Haemorrhage  1/164 (0.61%)  1/156 (0.64%) 
Arthralgia  0/164 (0.00%)  1/156 (0.64%) 
Groin Pain  0/164 (0.00%)  1/156 (0.64%) 
Muscular Weakness  0/164 (0.00%)  1/156 (0.64%) 
Nervous system disorders     
Cerebrovascular Accident  1/164 (0.61%)  0/156 (0.00%) 
Clonus  0/164 (0.00%)  1/156 (0.64%) 
Neuropathy Peripheral  0/164 (0.00%)  1/156 (0.64%) 
Tremor  0/164 (0.00%)  1/156 (0.64%) 
Renal and urinary disorders     
Renal Failure Acute  4/164 (2.44%)  2/156 (1.28%) 
Renal Impairment  3/164 (1.83%)  2/156 (1.28%) 
Haematuria  1/164 (0.61%)  1/156 (0.64%) 
Ureteric Obstruction  1/164 (0.61%)  1/156 (0.64%) 
Ureteric Stenosis  1/164 (0.61%)  1/156 (0.64%) 
Hydronephrosis  1/164 (0.61%)  0/156 (0.00%) 
Renal Artery Stenosis  1/164 (0.61%)  0/156 (0.00%) 
Renal Failure  0/164 (0.00%)  1/156 (0.64%) 
Renal Tubular Disorder  0/164 (0.00%)  1/156 (0.64%) 
Renal Tubular Necrosis  0/164 (0.00%)  1/156 (0.64%) 
Renal Vein Thrombosis  1/164 (0.61%)  0/156 (0.00%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia  1/164 (0.61%)  1/156 (0.64%) 
Respiratory, thoracic and mediastinal disorders     
Lung Disorder  1/164 (0.61%)  2/156 (1.28%) 
Pulmonary Embolism  1/164 (0.61%)  1/156 (0.64%) 
Acute Pulmonary Oedema  0/164 (0.00%)  1/156 (0.64%) 
Pulmonary Oedema  1/164 (0.61%)  0/156 (0.00%) 
Respiratory Failure  0/164 (0.00%)  1/156 (0.64%) 
Surgical and medical procedures     
Ureteral Stent Removal  1/164 (0.61%)  0/156 (0.00%) 
Vascular disorders     
Lymphocele  2/164 (1.22%)  3/156 (1.92%) 
Deep Vein Thrombosis  2/164 (1.22%)  1/156 (0.64%) 
Hypotension  2/164 (1.22%)  0/156 (0.00%) 
Phlebitis  2/164 (1.22%)  0/156 (0.00%) 
Arterial Stenosis  1/164 (0.61%)  0/156 (0.00%) 
Haemorrhage  1/164 (0.61%)  0/156 (0.00%) 
Iliac Artery Stenosis  1/164 (0.61%)  0/156 (0.00%) 
Shock Haemorrhagic  1/164 (0.61%)  0/156 (0.00%) 
Venous Thrombosis  0/164 (0.00%)  1/156 (0.64%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valganciclovir up to 100 Days Valganciclovir up to 200 Days
Affected / at Risk (%) Affected / at Risk (%)
Total   133/164 (81.10%)   141/156 (90.38%) 
Blood and lymphatic system disorders     
Leukopenia  41/164 (25.00%)  58/156 (37.18%) 
Anaemia  29/164 (17.68%)  24/156 (15.38%) 
Neutropenia  22/164 (13.41%)  16/156 (10.26%) 
Thrombocytopenia  6/164 (3.66%)  8/156 (5.13%) 
Gastrointestinal disorders     
Diarrhoea  41/164 (25.00%)  48/156 (30.77%) 
Constipation  24/164 (14.63%)  14/156 (8.97%) 
Nausea  18/164 (10.98%)  17/156 (10.90%) 
Abdominal Pain  12/164 (7.32%)  8/156 (5.13%) 
Vomiting  6/164 (3.66%)  10/156 (6.41%) 
Abdominal Pain Upper  7/164 (4.27%)  8/156 (5.13%) 
Dyspepsia  3/164 (1.83%)  11/156 (7.05%) 
General disorders     
Oedema Peripheral  35/164 (21.34%)  30/156 (19.23%) 
Pyrexia  17/164 (10.37%)  10/156 (6.41%) 
Fatigue  7/164 (4.27%)  14/156 (8.97%) 
Infections and infestations     
Urinary Tract Infection  20/164 (12.20%)  29/156 (18.59%) 
Nasopharyngitis  17/164 (10.37%)  12/156 (7.69%) 
Upper Respiratory Tract Infection  14/164 (8.54%)  14/156 (8.97%) 
Investigations     
Blood Creatinine Increased  11/164 (6.71%)  9/156 (5.77%) 
Metabolism and nutrition disorders     
Hypophosphataemia  20/164 (12.20%)  18/156 (11.54%) 
Hyperkalaemia  20/164 (12.20%)  14/156 (8.97%) 
Hypomagnesaemia  17/164 (10.37%)  10/156 (6.41%) 
Nervous system disorders     
Tremor  19/164 (11.59%)  25/156 (16.03%) 
Headache  16/164 (9.76%)  9/156 (5.77%) 
Psychiatric disorders     
Insomnia  12/164 (7.32%)  10/156 (6.41%) 
Renal and urinary disorders     
Haematuria  7/164 (4.27%)  9/156 (5.77%) 
Respiratory, thoracic and mediastinal disorders     
Cough  17/164 (10.37%)  7/156 (4.49%) 
Dyspnoea  9/164 (5.49%)  6/156 (3.85%) 
Oropharyngeal Pain  6/164 (3.66%)  8/156 (5.13%) 
Skin and subcutaneous tissue disorders     
Rash  9/164 (5.49%)  5/156 (3.21%) 
Vascular disorders     
Hypertension  21/164 (12.80%)  19/156 (12.18%) 
Hypotension  10/164 (6.10%)  3/156 (1.92%) 
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00294515     History of Changes
Other Study ID Numbers: NT18435
First Submitted: February 21, 2006
First Posted: February 22, 2006
Results First Submitted: June 2, 2010
Results First Posted: July 5, 2010
Last Update Posted: March 29, 2018