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NCT ID: NCT00492635 Completed - Clinical trials for Erectile Dysfunction

Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED

Start date: December 2004
Phase: Phase 3
Study type: Interventional

A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.

NCT ID: NCT00492271 Terminated - Clinical trials for Community Acquired Pneumonia

First Time in Man Trial for Friulimicin B

Start date: June 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to study the safety of single doses and multiple doses of Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.

NCT ID: NCT00491582 Completed - Clinical trials for Growth Hormone Deficiency

The Effects of Growth Hormone (GH) on Lipid Depots

Start date: July 2007
Phase: N/A
Study type: Interventional

This study aims at investigating the effect of growth hormone on lipid-content of muscle and liver as well as visceral fat mass in relation to insulin sensitivity. In addition, hormonal regulation and free fatty availability is assessed during a physical exercise at 50-60% VO2max. Finally, the value of physical exercise in diagnosing growth hormone deficiency is investigated. Hypothesis: 1) Lipid content of muscle and liver change with physical exercise and exercise capacity and free fatty availability will influence these changes. 2)Growth hormone replacement therapy will predominantly reduce visceral fat mass and increase free fatty availability. 3)Free fatty availability during exercise will be reduced in growth hormone deficient patients 4)Physical exercise may be an alternative way to diagnose growth hormone deficiency

NCT ID: NCT00490360 Completed - Clinical trials for Cancer of the Pancreatic Head

Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

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

Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.

NCT ID: NCT00490139 Completed - Neoplasms, Breast Clinical Trials

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ALTTO
Start date: May 16, 2007
Phase: Phase 3
Study type: Interventional

This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.

NCT ID: NCT00490074 Completed - HIV Infections Clinical Trials

Study to Compare the Immunogenicity and Safety of Two HIV Preventive Vaccinations in Healthy Volunteers

EV03/ANRSVAC20
Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the trial is to evaluate the effect upon immune system of two regimens of preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the vaccines. Volunteers will be followed during 72 weeks.

NCT ID: NCT00490035 Completed - Epilepsy Clinical Trials

Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

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

This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

NCT ID: NCT00489853 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD

CODEX
Start date: July 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.

NCT ID: NCT00488540 Completed - Pain Clinical Trials

Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery?

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

There are many reasons for using a vacuum apparatus or forceps to assist in delivering a baby. The traction and pressure on the baby`s head due to the vacuum apparatus or forceps may cause pain and discomfort for some time after the delivery. To date, the pain experienced by the newborn and the potential beneficial effects of pain medications after vacuum or forceps deliveries have not been systematically studied. It is possible that administration of paracetamol suppositories to the newborn may be helpful in these situations, since this medication is known to ameliorate pain in older children and adults.

NCT ID: NCT00488384 Withdrawn - Clinical trials for Carcinoma, Squamous Cell

Acitretin Plasma Levels Under Hemodialysis

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

Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.