Novartis

  • user warning: Table './intheclinic/captcha_sessions' is marked as crashed and should be repaired query: INSERT into captcha_sessions (uid, sid, ip_address, timestamp, form_id, solution, status, attempts) VALUES (0, '4p5blmrc57v9vrsmbgk740gej7', '38.107.191.116', 1268297207, 'user_login_block', 'undefined', 0, 0) in /persistent/html/sites/all/modules/captcha/captcha.inc on line 92.
  • user warning: Table './intheclinic/captcha_sessions' is marked as crashed and should be repaired query: SELECT status FROM captcha_sessions WHERE csid = 0 in /persistent/html/sites/all/modules/captcha/captcha.inc on line 112.
  • user warning: Table './intheclinic/captcha_sessions' is marked as crashed and should be repaired query: SELECT status FROM captcha_sessions WHERE csid = 0 in /persistent/html/sites/all/modules/captcha/captcha.inc on line 112.
  • user warning: Table './intheclinic/captcha_sessions' is marked as crashed and should be repaired query: UPDATE captcha_sessions SET timestamp=1268297207, solution='1' WHERE csid=0 in /persistent/html/sites/all/modules/captcha/captcha.inc on line 104.

Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

Trial phase: 
Phase II
Recruitment status: 
Active, not recruiting

To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration.

Background information
Trial ID: 
NCT00729846
Other unique IDs: 
BPDT2006
Official title: 

Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration

Detailed description: 

 

Number to be enrolled: 
22 patients

Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients

Trial phase: 
Phase I
Recruitment status: 
Recruiting

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients

Background information
Trial ID: 
NCT00724776
Other unique IDs: 
CABF656A1202
Official title: 

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Dose of Albinterferon Alfa 2b (Alb-IFN), Recombinant Human Albumin-Interferon Alfa Fusion Protein in Japanese Chronic Hepatitis C Patients.

Detailed description: 

 

Number to be enrolled: 
30 patients

Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The proposed study is aimed to assess the safety and immunogenicity of rMenB when administered with or without routine infant vaccinations to healthy infants in their first year of life according to different immunization schedules. This study will also demonstrate that the immunogenicity of routine infant vaccines when given concomitantly with rMenB at 2, 3 and 4 months of age, is non-inferior to that of routine infant vaccines given without rMenB.

Background information
Trial ID: 
NCT00721396
Other unique IDs: 
V72P12
Official title: 

A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants

Detailed description: 

 

Number to be enrolled: 
1800 patients

3-Year Efficacy and Safety Study of Zoledronic Acid in Post-Menopausal Women With Osteoporosis Treated With Zoledronic Acid for 6 Years

Trial phase: 
Phase III
Recruitment status: 
Enrolling by invitation

This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

Background information
Trial ID: 
NCT00718861
Other unique IDs: 
CZOL446H2301E2
Official title: 

A 3-Year, Multicenter, Double-Blind, Randomized, Placebo-Controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis

Detailed description: 

 

Number to be enrolled: 
400 patients

Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients

Trial phase: 
Phase II
Recruitment status: 
Enrolling by invitation

This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary read-out of efficacy is reduction in Aberrant-Behavior Checklist score.

Background information
Trial ID: 
NCT00718341
Other unique IDs: 
CAFQ056A2204
Official title: 

A Multi-Centre, Randomized, Double-Blind, Placebo Controlled, Two-Period, Crossover Proof-of-Concept Study in Male Patients With Fragile X Syndrome to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of AFQ056

Detailed description: 

 

Number to be enrolled: 
30 patients

Efficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase)

Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

This study will evaluate the safety and tolerability of nilotinib after failure of imatinib therapy or imatinib therapy after nilotinib failure.

Background information
Trial ID: 
NCT00718263
Other unique IDs: 
CAMN107A2303E1
Official title: 

Extension Study to a Phase III Multi-Center, Open-Label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosomepositive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Detailed description: 

 

Number to be enrolled: 
90 patients

Prospective, 6 Month, Open Label, Conversion Study From Mycophenolate Mofetil (MMF) to PRMYFORTIC*

Recruitment status: 
Recruiting

Treatment with MMF often results in adverse GI events, which can lead to dose reductions of MMF and decreased graft function. Enteric-coated mycophenolate sodium (MYFORTIC*) was developed as an alternative formulation of MPA to improve upper GI tract side effects. An improvement in the severity of GI side effects could result in an increased tolerance to MPA and an improvement in patient quality of life. This study will use the GSRS to evaluate improvement in gastrointestinal symptoms.

Background information
Trial ID: 
NCT00715468
Other unique IDs: 
CERL080ACA07
Official title: 

Prospective, 6 Month, Open Label, Conversion Study From MMF to PRMYFORTIC* Evaluating the Severity of GI Symptoms and MPA Metabolite as a Surrogate Marker of MYFORTIC

Detailed description: 

This study will evaluate the change in the total gastrointestinal symptom rating scale (GSRS) score at baseline versus month 1,at baseline versus month 3 and at baseline versus month 6 after conversion from MMF to PRMYFORTIC* .

Number to be enrolled: 
65 patients

Study Evaluating Conversion From Tacrolimus to Sirolimus in Stable Kidney Transplant Recipients Receiving Myfortic

The purpose of this study is to determine whether the combination of Myfortic and sirolimus is effective at preventing rejection while preserving kidney function in stable kidney transplant recipients.

Background information
Other unique IDs: 
KTXP_US28_MYFIIRP07

Single Dosing of Zoledronic Acid in Cancer Therapy Induced Bone Loss (CTIBL)

The purpose of this research is to establish if a once a year dose of Zoledronic Acid is sufficient to suppress and maintain urine bone density markers (NTx) within normal range at 12 months post-dosing in postmenopausal early breast cancer patients receiving additional treatment with non-steroidal aromatase inhibitors.

Background information
Other unique IDs: 
CZOL446H US113

2 Week Open-Label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (6 - 15 Yrs) With Neurogenic Detrusor Overactivity

Trial phase: 
Phase II
Recruitment status: 
Recruiting

This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 6-15 years, with neurogenic detrusor overactivity. The results will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.

Background information
Trial ID: 
NCT00712322
Other unique IDs: 
CDAR328B2201
Official title: 

A 14-Day, Open-Label, Multicenter, Dose-Escalating, Sequential Cohort Study to Evaluate Pharmacodynamics (Urodynamics) and Pharmacokinetics, Clinical Efficacy, Tolerability and Safety, Following Multiple Doses (mg/kg/Day) of a Darifenacin Liquid Oral Susp

Detailed description: 

 

Number to be enrolled: 
60 patients
Syndicate content