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An Open-label Trial Investigating the Association Between Nocturia Symptoms and Sleep During 12 Weeks of Treatment with desmopressin ODT for Nocturia due to Nocturnal Polyuria in Adults

Primary Objective* To assess the association between changes in the number of nocturnal voids and change in Nocturia Sleep Quality Scale (NSQS) total score in adult subjects with nocturia due to Nocturnal Polyuria (NP)Secondary Objectives* To assess…

A Multi-Center,Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the ESSURE (Model ESS505) Device to Prevent Pregnancy in Women Who are Seeking Permanent Contraception

Evaluate the safety and effectiveness of the Essure System for Permanent Birth Control (Model ESS505) in preventing pregnancy

A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in which
Peginterferon Lambda 1-a (BMS-914143) was Administered for the Treatment of Chronic Hepatitis C

Recent studies demonstrate long-term durability of virologic response with pegylated alpha-interferon-based therapies. Comparable information is not yet available for Lambda or for regimens combining lambda interferons, RBV, and DAAs. In this…

Multicentre, Open-Label Trial to Assess the Safety and Tolerability of LF111 (Drospirenone 4.0 mg) Over 6 Cycles in Female Adolescents, With a 7-Cycle Extension Phase

It is expected that LF111 will offer benefits to adults in the form of efficacy similar to COCPs, absence of estrogen-related risks, reduced tendency to weight gain and extended dosing window. It is likely that adolescents will share these benefits…

Multi-center, single-arm study to assess the safety, efficacy, discontinuation rate and pharmacokinetics of the low-dose levonorgestrel intrauterine contraceptive system (LCS12) in post-menarcheal female adolescents under 18 years of age for 1 year, and an optional 2-year extension phase

The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. The incidence of adverse events over 12 month treatment period will be the main…

An open- label, multi-site trial to describe the safety and tolerability of oral cebranopadol administered for 26 weeks in subjects with cancer- related pain who have completed treatment in the KF6005/07 trial.

The primary objective of this trial is to describe the safety and tolerability of prolonged exposure to cebranopadol in subjects suffering from cancer related pain

Prospective, open label TElmisartan/AMlodipine single pill STudy to Assess the efficacy in patients with essential hypertension who are not controlled on RAASi mono-therapy being switched.

The primary objective of this study is to evaluate the blood pressure control rate after 12 weeks of treatment with telmisartan/amlodipine FDC in patients who were previously not controlled on RAAS blocking mono-therapy (ARBs, ACEi, DRI).

An Open-Label Phase III Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in an Adult and Elderly Population as well as in Specified Risk Groups

- To assess the safety and tolerability of a nonadjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups;- To assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and…

Clinical Protocol AI447-029
A Phase 3, Open-Label Study with Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin with Chronic Hepatitis C Genotypes 1 or 4 Infection

Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…

Knee joint replacement over 5 years in patients with knee osteoarthritis. A long term follow up study in patients of the CL3-12911-018 study.

To collect data on knee joint replacement procedures or procedurespracticed in the knee (arthroscopy, osteotomy or other) over 5 years inpatients with knee osteoarthritis having participated in the CL3-12911-018 study and having received at least…

Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses (in vitro 12 µg/24 h and 16 µg/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age with an extension of the LCS16 treatment arm up to five years

The objective of this study is to assess the safety, efficacy and pharmacokinetics of 2 doses of LNG, delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 35 years of age during 3 years and with an extension…

Paracetamol intravenously in neonates with a gestational age of less than 32 weeks

Primary objective: to study the pharmacokinetics and pharmacodynamics of paracetamol intravenously in preterm infants with a gestational age of less than 32 weeks:Secondary objective(s): to study the safety and dose-effect relationship of…

An Open Label, Single Arm, Extension Study to Evaluate the Long Term
Safety of Denosumab (AMG162) in the Treatment of Bone Loss in Subjects
Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate
Cancer

To study the long term safety (up to 5 years) of denosumab in subjects undergoing androgen-deprivation therapy for non-metastatic prostate cancer.

A 52-Week Open-Label Extension and Safety Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood (NK-104-4.02EU).

The primary objective of this study is to assess the safety of pitavastatin 1 mg QD, 2 mg QD, and 4 mg QD in children or adolescent patients with high-risk hyperlipidaemia over a period of 52 weeks.The secondary objective of this study is to assess…

Renal hemodynamic effects of aliskiren (rasilez) in comparison to ramipril (tritrace) in patients with overweight/obesity and hypertension

The primary objective of this study is to determine the effects of aliskiren, as compared to ramipril, on renal hemodynamics in overweight/obese and hypertensive patients.

Innovative approaches for cocaine pharmacotherapy using fMRI: The case of varenicline

Drug craving and impulsivity will be assessed with questionnaires, fMRI/EEG using cue-reactivity and impulsivity paradigms. Relapse will be assessed by checking urine samples every week.

Innovative approaches for cocaine pharmacotherapy using fMRI and SPECT: The case of rimonabant

Striatal D2 receptor availability will be ascertained in 30 recent abstinent cocaine addicts by [123I]IBZM SPECT. In addition, we will measure drug craving and impulsivity with questionnaires, fMRI/EEG using cue-reactivity and impulsivity paradigms…

Desensitization of highly pre-sensitized dialysis patients waiting for kidney transplantation by Rituximab, IVIG-L and rescue Plasmapheresis
THE DRIP STUDY

1. Primary end point is achievement of a negative cross-match test with the donor kidney and transplantability.2. Secondary objectives are patient and graft survival, graft function as assessed by calculated creatinine clearance, proteinuria, the…

A twenty-six weeks, open-label extension trial to evaluate safety and efficacy of Org 50081 in outpatients with chronic primary insomnia who completed clinical trial protocol 21106

To investigate safety and tolerability and to collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.

Diagnose of GH-deficiency: comparing the reliability of a dietary-protein test with conventional Growth Hormone Stimuation Tests

Comparing the reliability of a dietary-protein test with conventional Growth Hormone Stimulation Tests.