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NCT ID: NCT01344889 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)

Start date: October 2009
Phase: N/A
Study type: Observational

This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.

NCT ID: NCT01342952 Completed - Clinical trials for Hypertension, Pulmonary

Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529

Start date: June 21, 2011
Phase: Phase 2
Study type: Interventional

An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months. Beyond the six month period, subjects may continue in the extension study until one of the following conditions is met: the subject turns 18 years of age (when the subject can receive marketed product) the product is approved and available for use in the subject's age group, development for use in the paediatric population is discontinued. the subject decides he/she no longer wants to participate in the study, the investigator considers it is in the best interest of the subject to discontinue ambrisentan (e.g. for safety reasons). The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population. Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters.

NCT ID: NCT01340027 Completed - Urologic Diseases Clinical Trials

A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

Symphony
Start date: March 29, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

NCT ID: NCT01339923 Completed - Clinical trials for Meningococcal Disease

A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. This study will also investigate antibody persistence post primary series and administration of a subsequent booster dose of rMenB+OMV NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of age. This study will also evaluate the safety and immunogenicity of the concomitant administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and 12-month schedule.

NCT ID: NCT01339559 Completed - Epilepsy Clinical Trials

Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

BRITEā„¢
Start date: May 11, 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

NCT ID: NCT01339260 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

Start date: April 2011
Phase: Phase 3
Study type: Interventional

NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.

NCT ID: NCT01338870 Completed - Clinical trials for Diabetes Mellitus, Type 2

Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes

Start date: June 2011
Phase: Phase 2
Study type: Interventional

B2611003 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

NCT ID: NCT01338805 Completed - Clinical trials for Partial Onset Seizures

Phase II BGG492 Capsule Extension for Partial Epilepsy

Start date: June 2011
Phase: Phase 2
Study type: Interventional

This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as adjunctive treatment in patients with partial onset seizures.

NCT ID: NCT01338415 Completed - Clinical trials for Pulmonary Arterial Hypertension

FUTURE 3 Study Extension

FUTURE 3 Ext
Start date: March 8, 2011
Phase: Phase 3
Study type: Interventional

The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

NCT ID: NCT01337089 Completed - Pain Clinical Trials

Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

Start date: January 19, 2011
Phase: Phase 3
Study type: Interventional

This was a six-month open-label extension (OLE) study to evaluate the safety of long-term nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding Phase 3 study and new (de novo) participants.