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NCT ID: NCT00668148 Completed - Rhabdomyosarcoma Clinical Trials

A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma

Start date: July 2008
Phase: Phase 2
Study type: Interventional

This multicenter study will enroll approximately 185 participants with metastatic or advanced sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication. Participants will be stratified into five tiers according to diagnosis: 1. Ewing's sarcoma/peripheral neuroectodermal tumor (PNET) 2. rhabdomyosarcoma 3. leiomyosarcoma 4. adipocytic sarcoma 5. synovial sarcoma. A total of 85 participants will be enrolled initially, 17 in each tier. Participants will receive single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. Safety and response in the initial 17 participants in each tier will be used to determine whether to extend enrollment to the target total of 37 participants per tier.

NCT ID: NCT00668109 Completed - Clinical trials for Erectile Dysfunction

Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

LUTECIA
Start date: December 2003
Phase: Phase 3
Study type: Interventional

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

NCT ID: NCT00667823 Completed - Clinical trials for Pulmonary Arterial Hypertension

Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

SERAPHIN OL
Start date: October 17, 2008
Phase: Phase 3
Study type: Interventional

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

NCT ID: NCT00667251 Completed - Breast Cancer Clinical Trials

Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer

Start date: October 7, 2008
Phase: Phase 3
Study type: Interventional

RATIONALE: HER2/neu is a receptor (protein) which is found in unusually high amounts in approximately 1 in 5 cancer patients. Scientific evidence suggests that having high amounts of the HER2/neu receptor is important for breast cancer to grow and spread. Women with previously untreated metastatic breast cancer (breast cancer that has spread to other organs) and with high levels of the HER2/neu receptor receive as their usual treatment chemotherapy with one of the approved chemotherapy drugs paclitaxel or docetaxel (called "taxanes") together with another approved drug called "trastuzumab". Chemotherapy drugs, such as paclitaxel and docetaxel, work either by killing tumour cells or by stopping them from dividing. Trastuzumab is an antibody that is given through a vein in the arm and it works by specifically "targeting" the HER2/neu i.e. it attaches to it and "turns it off". Although some of the patients who receive this taxane plus trastuzumab treatment feel better for some months, the cancer usually starts to grow again. Lapatinib is a new drug. Like trastuzumab, it also works by specifically "targeting" the HER2/neu receptor, but it does so in a different way. Lapatinib is not an antibody. It is a pill that is taken daily by mouth. Because lapatinib works in a different way than trastuzumab, it may be worse, as good as or better than trastuzumab in keeping metastatic HER/neu positive cancer from growing. However, this is not known. Purpose: This randomized Phase III trial is comparing chemotherapy (a taxane) given together with lapatinib with chemotherapy (a taxane) given together with trastuzumab in women with HER2/neu positive breast cancer.

NCT ID: NCT00665951 Completed - HIV Infections Clinical Trials

Pharmacokinetic Study of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)

SURF
Start date: September 2008
Phase: Phase 1
Study type: Interventional

This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded formulation. The formal bioequivalence study with adequate power will be conducted by the manufacturer. In order to get data independently from the manufacturer and to have this information in an earlier phase, this small pilot study is initiated. The initial study showed a declined bioavailability of the granules under fasting conditions. The study has been extended with an arm determining the pharmacokinetics of the granules after food (compared to the oral solution taken with food).

NCT ID: NCT00665847 Completed - HIV-1 Clinical Trials

TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents

Start date: November 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.

NCT ID: NCT00665717 Completed - HIV Infections Clinical Trials

The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

GRAPPA
Start date: May 2008
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.

NCT ID: NCT00665496 Completed - Clinical trials for Erectile Dysfunction

A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

Start date: June 2003
Phase: Phase 3
Study type: Interventional

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

NCT ID: NCT00665379 Completed - Leg Lymphedema Clinical Trials

Comparative Trial in Compression Therapy in Leg Lymphedema

Start date: April 2008
Phase: N/A
Study type: Interventional

The purpose of this trial is to study the effect of the 3M Coban 2 Layer Compression System (hereafter C2L) in the treatment of leg lymphedema compared to the traditional treatment with Trico bandages.

NCT ID: NCT00664521 Completed - Clinical trials for Rheumatoid Arthritis

Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis

August III
Start date: March 2008
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis receiving re-treatment with rituximab.