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NCT ID: NCT00319267 Completed - Clinical trials for Pulmonary Arterial Hypertension

Bosentan in Children With Pulmonary Arterial Hypertension

FUTURE-1
Start date: May 2005
Phase: Phase 3
Study type: Interventional

The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension, using a pediatric formulation, is similar to that in adults with PAH and to evaluate the tolerability and safety of a pediatric formulation of bosentan in this patient population.

NCT ID: NCT00319215 Completed - Insomnia Clinical Trials

Effects of Ramelteon on Driving Ability

Start date: March 2006
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.

NCT ID: NCT00319111 Completed - Clinical trials for Pulmonary Hypertension

Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

BENEFIT OL
Start date: January 2006
Phase: Phase 3
Study type: Interventional

The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

NCT ID: NCT00319098 Completed - Influenza Clinical Trials

Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

Start date: May 1, 2006
Phase: Phase 3
Study type: Interventional

Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

NCT ID: NCT00319046 Completed - Clinical trials for Gaucher Disease Type 1

Clinical Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Miglustat in Patients With Stable Type 1 Gaucher Disease

Start date: February 1, 2006
Phase: Phase 3
Study type: Interventional

Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are required to establish the long term efficacy, safety and tolerability of miglustat in maintaining diseases stability after a switch from ERT.

NCT ID: NCT00319033 Completed - Clinical trials for Interstitial Lung Disease

Open-label Study With Bosentan in Interstitial Lung Disease

BUILD 2 OL
Start date: July 2004
Phase: Phase 2/Phase 3
Study type: Interventional

This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.

NCT ID: NCT00319020 Completed - Clinical trials for Pulmonary Arterial Hypertension

Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

FUTURE 2
Start date: August 2005
Phase: Phase 3
Study type: Interventional

The main objective of the FUTURE-2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension who completed FUTURE-1 study.

NCT ID: NCT00318799 Completed - Clinical trials for Pregnancy, Unplanned

Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters

Start date: April 2006
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.

NCT ID: NCT00318539 Completed - Clinical trials for Obsessive Compulsive Disorder

Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

Start date: December 2003
Phase: Phase 2
Study type: Interventional

Quetiapine (Seroquel ®), an atypical antipsychotic registered for use in schizophrenia, which has a very low propensity of extrapyramidal and endocrine side-effects, has also been studied as an adjunct in OCD. In an open trial, ten patients with OCD who had not responded to at least three previous treatments with a SRI at maximum dose and duration were assigned to receive quetiapine in addition to a SRI for 8 weeks. Given the efficacy of quetiapine in treatment resistant patients, and given its rapid onset of action (4-6 weeks), it is postulated that the combination of a low dose atypical antipsychotic and a standard dosage of an SRI as a treatment for patients with OCD might increase the number of responders as well as the effect size. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

NCT ID: NCT00318461 Completed - Clinical trials for Diabetes Mellitus, Type 2

To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together

LEAD-2
Start date: May 2006
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).