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NCT ID: NCT00472199 Completed - Clinical trials for Restless Legs Syndrome

Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)

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

The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo. The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.

NCT ID: NCT00471497 Completed - Clinical trials for Myelogenous Leukemia, Chronic

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

ENESTnd
Start date: July 31, 2007
Phase: Phase 3
Study type: Interventional

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.

NCT ID: NCT00471003 Completed - Hypertension Clinical Trials

The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension

METABOLIC
Start date: September 2006
Phase: N/A
Study type: Observational

The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.

NCT ID: NCT00470886 Completed - Hypertension Clinical Trials

Assessment of Compliance With Antihypertensive Telmisartan Therapy

COAST
Start date: April 2007
Phase: N/A
Study type: Observational

The purpose of this study is to asses the efficacy and safety of Telmisartan depending on the use of an electronic therapy monitoring device (HelpingHand) in a real life setting and to asses patients compliance to the therapy with Telmisartan in relation to use of electronic therapy monitoring device.

NCT ID: NCT00466167 Completed - Parkinson Disease Clinical Trials

Pivotal Study in Advanced Parkinsons Disease Patients

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

The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations. In addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done. The efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.

NCT ID: NCT00460408 Completed - Clinical trials for Macular Degeneration

Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

Start date: August 2006
Phase: N/A
Study type: Observational

The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.

NCT ID: NCT00457691 Completed - Clinical trials for Metastatic Colorectal Cancer

Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

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

The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.

NCT ID: NCT00457457 Completed - Clinical trials for Prostatic Hyperplasia

Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

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

This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.

NCT ID: NCT00457392 Completed - Clinical trials for Carcinoma, Non-Small Cell Lung

A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

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

This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.

NCT ID: NCT00454779 Completed - Clinical trials for Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

Start date: January 1, 2007
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.