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NCT ID: NCT00777920 Completed - Clinical trials for Pulmonary Hypertension

Study of Ambrisentan in Participants With Pulmonary Hypertension

ABS-LT
Start date: November 17, 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to monitor the long-term safety of ambrisentan in adult participants with pulmonary hypertension. The available ambrisentan doses for this study are 2.5, 5, or 10 mg administered orally once daily. Investigators will be able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose adjustments is required. Participants receiving other therapies for pulmonary hypertension that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in this study and continue to receive such therapies. Participants enrolled in this study will receive treatment with ambrisentan until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.

NCT ID: NCT00768300 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF

ARTEMIS-IPF
Start date: December 2008
Phase: Phase 3
Study type: Interventional

The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

NCT ID: NCT00763451 Completed - Clinical trials for Diabetes Mellitus, Type 2

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

GETGOAL-F1
Start date: September 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

NCT ID: NCT00762736 Completed - Diabetes Mellitus Clinical Trials

Efficacy and Safety of Pioglitazone and Azilsartan in Treating Subjects With Type 2 Diabetes Mellitus

Start date: July 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of pioglitazone, once daily (QD), combined with azilsartan in the treatment of subjects with Type 2 Diabetes Mellitus.

NCT ID: NCT00754572 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Start date: February 2009
Phase: Phase 3
Study type: Interventional

This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is <500 individuals.

NCT ID: NCT00751881 Completed - Multiple Sclerosis Clinical Trials

An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis

TOWER
Start date: August 2008
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the effect of two doses of Teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in patients with relapsing MS. Key secondary objective is to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression. Other secondary objectives are: - To assess the effect of the two doses of teriflunomide in comparison to placebo on: - Fatigue; - Health-related quality of life, a measure of the impact of the patient's health on his or her overall well being. - To evaluate the safety and tolerability of teriflunomide.

NCT ID: NCT00749645 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult Patients

FANG30-RA
Start date: October 2006
Phase: Phase 2
Study type: Interventional

This is a Clinical Pilot Phase II interventional, double blind, randomized and placebo controlled study to document the efficacy, tolerability and safety of FANG(30) in 60 adult patients affected with active Rheumatoid Arthritis. Also, to evaluate the effect of an andrographolide natural formula, identified as FANG(30) or "the study product", on the immunological functions that influence chronic inflammatory process in these patients, who could benefit with this treatment.

NCT ID: NCT00744341 Terminated - Clinical trials for Acute Decompensated Heart Failure; Renal Dysfunction

Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure

Start date: February 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

NCT ID: NCT00735397 Completed - Epilepsy Clinical Trials

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

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

The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

NCT ID: NCT00735137 Completed - Preterm Birth Clinical Trials

Randomized Study of Pessary Versus Standard Management in Women With Increased Chance of Premature Birth

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

The aim of the study is to determine the effect of cerclage pessary on the incidence of spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic women with singleton pregnancies found at routine mid-trimester screening to have a cervix of <25 mm in length and in twin pregnancies.