Clinical Trials Logo

Filter by:
NCT ID: NCT00553358 Completed - Neoplasms, Breast Clinical Trials

Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study

Neo ALTTO
Start date: January 5, 2008
Phase: Phase 3
Study type: Interventional

This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer. Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg intravenous (IV) load followed by 2 mg/kg IV weekly, or lapatinib 1000 mg daily with trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for a total of 6 weeks. After this biological window, patients on monotherapy arms will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m^2 for a further 12 weeks, up to definitive surgery. In the combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab 2 mg/kg IV plus weekly paclitaxel 80mg/m^2 IV for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with 5-Fluorouracil Epirubicin Cyclophosphamide (FEC) followed by the same targeted therapy as in the biological window of the neoadjuvant setting for a further 34 weeks (in the combination arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total duration of the anti-HER2 therapy one year. Primary objective is to evaluate and compare the rate of pathological complete response (pCR) at the time of surgery in patients with HER2/ErbB2 overexpressing or amplified operable breast cancer randomised to lapatinib followed by lapatinib plus paclitaxel versus trastuzumab followed by trastuzumab plus paclitaxel versus lapatinib in combination with trastuzumab followed by lapatinib, trastuzumab plus paclitaxel.

NCT ID: NCT00552305 Completed - Partial Epilepsies Clinical Trials

To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

Start date: August 2001
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.

NCT ID: NCT00551642 Completed - Lung Disease Clinical Trials

Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

Start date: May 29, 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.

NCT ID: NCT00551135 Completed - Pain, Postoperative Clinical Trials

Surgical Pain After Inguinal Hernia Repair (SPAIHR)

Start date: January 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.

NCT ID: NCT00550238 Completed - Clinical trials for Parkinson's Disease Psychosis

A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

Start date: July 2007
Phase: Phase 3
Study type: Interventional

To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

NCT ID: NCT00549783 Completed - Muscle Spasticity Clinical Trials

BOTOX® Economic Spasticity Trial (BEST)

Start date: October 2007
Phase: Phase 4
Study type: Interventional

This is a study to investigate if patients who have had a stroke and suffer from spasticity might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to reduce spasticity significantly. Patients will be enrolled in this study at about 33 locations in Europe and Canada. Study participation will last for about 1 year.

NCT ID: NCT00549770 Completed - Hypertension Clinical Trials

Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

Start date: September 2007
Phase: Phase 2
Study type: Interventional

This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

NCT ID: NCT00549757 Terminated - Clinical trials for Type 2 Diabetes Mellitus

Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)

ALTITUDE
Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney. AMENDMENT 4 RATIONALE (MARCH 2012) : Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.

NCT ID: NCT00548496 Terminated - Fracture Healing Clinical Trials

A Phase IIa Study Of Men And Post-Menopausal Women With A Fractured Distal Radius

Start date: September 20, 2007
Phase: Phase 2
Study type: Interventional

This is a study designed to test the safety and effectiveness of SB-751689 in the treatment of a distal radius fracture in post-menopausal women and men in comparison to placebo to determine if healing time of the fracture can be decreased.

NCT ID: NCT00548431 Completed - Clinical trials for Leukemia, Lymphocytic, Acute

NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia

Start date: December 2007
Phase: Phase 2
Study type: Interventional

The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.