Merck

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A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents

Trial phase: 
Phase I
Recruitment status: 
Recruiting

This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.

Background information
Trial ID: 
NCT00730275
Other unique IDs: 
2008_540
MK0431-081
Official title: 

A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents

Detailed description: 

 

Number to be enrolled: 
36 patients

Phase I Imaging Study Evaluating MK0646 in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer

Trial phase: 
Phase I
Recruitment status: 
Recruiting

This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and MK0646 (Part II).

Background information
Trial ID: 
NCT00729742
Other unique IDs: 
2008_518
MK0646-008
Official title: 

A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer

Detailed description: 

 

Number to be enrolled: 
106 patients

Efficacy and Safety Study of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis

Trial phase: 
Phase III
Recruitment status: 
Completed

To demonstrate the efficacy/safety of FOSAMAX PLUS D.

Background information
Trial ID: 
NCT00729651
Other unique IDs: 
2008_015
MK217A-263
Official title: 

A Phase IV (Phase V Program), Prospective, Randomized, Open-Label, Active-Controlled, Clinical Trial to Study the Efficacy and Safety of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis

Detailed description: 

 

Number to be enrolled: 
350 patients

Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure

Trial phase: 
Phase II
Recruitment status: 
Completed

The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.

Background information
Trial ID: 
NCT00729222
Other unique IDs: 
2008_532
MK7418-503
Official title: 

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With Heart Failure

Detailed description: 

 

Number to be enrolled: 
16 patients

BMD Efficacy and Safety of Odanacatib in Postmenopausal Women

This study will evaluate the safety and treatment effect of 50 mg MK0822 with Vitamin D vs placebo with Vitamin D in postmenopausal women with low bone density.

Background information
Other unique IDs: 
2008_539
MK0822-031

Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy

Many IBD patients take immunosuppressive agents and we are uncertain as to their capacity to mount a truly protective response after vaccination. If IBD patients do not have an adequate immunological response, they may need to increase the dosage or get booster shots. Many clinicians who treat patients with autoimmune diseases are asking if the vaccine is safe and effective. Thus, this study has important clinical and public health significance because more than one million people in the United States who have been diagnosed with IBD. There is not much studied about HPV and immunocompromised patients. Research on healthy women who were immunized with a set of three HPV vaccines demonstrated significantly increased antibody titers. In addition, they had significantly reduced HPV incident and persistent infection and HPV-related disease (cervical, vulvar, and vaginal cancers, cervical intraepithelial neoplasia, genital warts) through five years of follow-up compared to controls who received a placebo. The HPV vaccine was well tolerated without significant side effects. The aims of this research are to measure the immune response in 9-26 year old IBD patients who are on immunosuppressive agents after receiving the HPV vaccine compared with controls. We will also evaluate the number and type of vaccine-associated adverse events as well as the disease activity and flare-ups that occur after each dose of vaccine. We hypothesize that IBD patients on immunosuppressive therapy will have an equivalent immune response to HPV types 6, 11, 16 and 18 at one month postdose 3 compared to healthy age-matched historical controls. The patient population includes IBD patients who are on immunosuppressive medications. Recruiting approximately 100 patients will provide adequate power for the study. A blood sample will be taken from all IBD patients to evaluate baseline antibody levels and markers (e.g., ESR, CBC, albumin) before or immediately after immunization with the HPV vaccine. Lab tests will be redrawn at 7 months to evaluate the level of antibody titers and follow the markers. During the study, we will track basic laboratory measures, disease status by using the Pediatric Crohn's Disease Active Index or Harvey-Bradshaw Index for UC, side effects from the vaccinations, and other adverse events.

Background information
Other unique IDs: 
07-09-0344

MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus

Trial phase: 
Phase III
Recruitment status: 
Recruiting

A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes

Background information
Trial ID: 
NCT00722371
Other unique IDs: 
2008_522
MK0431-102
Official title: 

A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Detailed description: 

 

Number to be enrolled: 
1295 patients

A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults

Trial phase: 
Phase I
Recruitment status: 
Completed

A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.

Background information
Trial ID: 
NCT00721461
Other unique IDs: 
2008_537
V930-001
Official title: 

Probe Study of the Tolerability of an Investigational Electroporation Device, MedPulser (Trademark) DNA Delivery System (DDS) in Healthy Adults 18 to 35 Years of Age

Detailed description: 

 

Number to be enrolled: 
24 patients

Investigation to Identify Predictors of Response to a Treatment With Montelukast

Trial phase: 
Phase IV
Recruitment status: 
Recruiting

The main aim of the study is to develop a method that allows responders to be distinguished from non-responders before long-term treatment is initiated. Subsidiary aims are to record changes in pulmonary functional parameters, NO concentrations and peak flow variability, the use of beta2 sympathomimetics and the asthma symptom score.

Background information
Trial ID: 
NCT00721240
Other unique IDs: 
Trial No. 25.08.2005
Official title: 

Investigation to Identify Predictors of Response to a Treatment With Montelukast

Detailed description: 

Leukotriene antagonists (montelukast) are particularly effective as controllers before exposure to an allergen (Leff 1998). The same applies to the treatment of bronchoconstriction induced by physical exertion or cold air (Richter 2000). Montelukast binds to the cysteinyl leuko¬triene-1 receptor, where it prevents leukotriene from binding. Leukotrienes play a key role as mediators in inflammatory processes. By binding to the receptor they cause, among other things, edema, damage to the bronchial epithelium and bronchoconstriction.

Number to be enrolled: 
50 patients

Study to Evaluate the Effect of Simvastatin, Losartan and Pioglitazone on Patients With Peripheral Arterial Disease.

Part A. The purpose of this study is to assess the effects of 6 weeks of treatment with, simvastatin, losartan or pioglitazone compared to placebo on the RNA expression profile of lower extremity peripheral arterial atherosclerotic plaque. Part B. The effect of simvastatin, losartan or pioglitazone compared to placebo on protein and lipid biomarkers in lower extremity peripheral arterial atherosclerotic plaque.

Background information
Other unique IDs: 
FHT-P-05-005
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