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Results 91 - 100 of 541

A Phase III, Randomized, Double Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MK-0517-031)

Recruitment Status
Completed
Project Status
Completed
Project Description
This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 and corticosteroid only, in preventing chemotherapy-in . . .
Primary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Study Type
Interventional
Date of Registration
17 January 2014
Date of FIrst Enrollment
12 March 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0030_2
Sources of Monetary or Material Support
Merck Sharp & Dohme (I.A.) LLC
Primary Outcomes
Original: Number of participants with Complete Response from 25 to 120 hours after initiation of MEC. [ Time Frame: Day 2 to Day 6 ] [ Designated as safety issue: No ] Number of participants with infusion-site thrombophlebitis [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ] Number of parti . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Has a histologically or cytologically confirmed malignant disease Is naive to moderately and highly emetogenic chemotherapy . . .
Countries of Recruitment
Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Finland, Germany, Greece, Hungary, India, Italy, Latvia, Mexico, Netherlands Antilles, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United States, Venezuela
Health Condition(s) or Problem(s) Studied
Chemotherapy-Induced Nausea and Vomiting

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16-to 26-Year-Old Men and 16-to 26-Year-Old Women.

Recruitment Status
Completed
Project Status
Completed
Project Description
Study participants will be administered a 3-dose regimen of V503. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.
Primary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Study Type
Interventional
Date of Registration
06 January 2014
Date of FIrst Enrollment
01 October 2013
Region
NCR
Method of Allocation
Non-randomized
Masking
Open-Label
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0053
Sources of Monetary or Material Support
Merck Sharp & Dohme (I.A.) LLC
Primary Outcomes
> Geometric mean titers (GMTs) to the HPV types contained in the V503 vaccine [ Time Frame: Four weeks post vaccination 3 ] [ Designated as safety issue: No ] > Number of participants with injection-site adverse experiences of erythema, pain, and swelling [ Time Frame: Day 1 through Day 5 followin . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Good physical health •Has never had Pap testing (cervical or anal) or has only had normal Pap test results •Other inclusion criteria will be discussed with the investigator Exclusion Criteria: •History of severe allergic reaction that required medical interven . . .
Countries of Recruitment
Canada, Colombia, Denmark, Germany, Israel, Malaysia, Mexico, Norway, Peru, Philippines, Poland, South Africa, Spain, Sweden, Thailand, Turkey, United States, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United States, Venezuela
Health Condition(s) or Problem(s) Studied
Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia

An Investigational Study of Gardasil™ (qHPV, V501) Vaccine in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

Recruitment Status
Completed
Project Status
Completed
Project Description
The base study (V501-020) encompassed Day 1 through Month 7, during which time participants received randomly assigned Gardasil™ (qHPV vaccine) or placebo at Day 1, Month 2, and Month 6. Base study follow-up continued through Month 36. The base study was extended in protocol V501-020-10 Extension . . .
Primary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Study Type
Interventional
Date of Registration
06 January 2014
Date of FIrst Enrollment
13 October 2010
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Merck Sharp & Dohme (I.A.) LLC
Primary Outcomes
•Incidence of Human Papillomavirus (HPV) Related External Genital Warts, Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer [ Time Frame: Base study: through Month 36 ] Subjects with HPV 6/11/16/18-related external genital warts, PIN, penile, perianal or . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: . . .
Countries of Recruitment
Australia, Brazil, Canada, Costa Rica, Finland, Germany, Mexico, Netherlands, Norway, Peru, Philippines, South Africa, Spain, Sweden, Taiwan, United States, United States, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United States, Venezuela
Health Condition(s) or Problem(s) Studied
Condylomata Acuminata

A Study to Test the Safety and Effectiveness of MK0906A (Finasteride) and Tamsulosin Taken Either Together or Alone in Patients with Benign Prostatic Hyperplasia (MK-0906A-149)

Recruitment Status
Terminated
Project Status
Terminated
Project Description
This study is designed to compare safety and efficacy of monotherapy finasteride to combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic hyperplasia (BPH) who are at least 50 years of age or older.
Primary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Study Type
Interventional
Date of Registration
07 February 2014
Date of FIrst Enrollment
01 October 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind (Subject, Investigator)
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Merck Sharp & Dohme (I.A.) LLC
Primary Outcomes
•Change from Baseline in International Prostate Symptom Score (IPSS) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ] •Change from Baseline in Prostate Volume [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Possess a clinical diagnosis of BPH. •Able to read, understand, and complete the study questionnaire. Exclusion Criteria: •History or recurrent evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, . . .
Countries of Recruitment
China, Colombia, Hong Kong, India, Malaysia, Mexico, Philippines, Netherlands, Norway, Peru, Philippines, South Africa, Spain, Sweden, Taiwan, United States, United States, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United States, Venezuela
Health Condition(s) or Problem(s) Studied
Benign Prostatic Hyperplasia

A multi-center, randomized, double-blind, active-controlled, 8-week study to evaluate the efficacy and safety of LCZ696 in comparison to olmesartan in patients withessential hypertension

Recruitment Status
Completed
Project Status
Completed
Project Description
Study of efficacy and safety of LCZ696 compared to olmesartan in patients with mild to moderate hypertension
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
06 January 2014
Date of FIrst Enrollment
02 December 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2013 CT0110
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
Objective: To evaluate the efficacy LCZ696 200 mg when compared to olmesartan 20 mg after 8 weeks of treatment, by testing: (i) the hypothesis of non-inferiority for the LCZ696 200 mg versus olmesartan 20 mg on reduction in msSBP from baseline and (ii) the hypothesis of superiority for the LCZ696 20 . . .
Key Inclusion and Exclusion Criteria
• Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy. o Pre-treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP ≥ 150 mmHg and < 180 mmHg at the randomization visit (Visit 201) and msSBP ≥140 m . . .
Countries of Recruitment
Philippines, Colombia, Hong Kong, India, Malaysia, Mexico, Philippines, Netherlands, Norway, Peru, Philippines, South Africa, Spain, Sweden, Taiwan, United States, United States, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United States, Venezuela
Health Condition(s) or Problem(s) Studied
Essential Hypertension

A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects (P07755)

Recruitment Status
Completed
Project Status
Completed
Project Description
The primary purpose of this study is to compare the efficacy of two boceprevir (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele. The regimens differ in the treatment for participants who achieve . . .
Primary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Study Type
Interventional
Date of Registration
22 October 2013
Date of FIrst Enrollment
25 February 2013
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Merck Sharp & Dohme (I.A.) LLC
Primary Outcomes
• Overall Number of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 [ Time Frame: Baseline to Follow-up Week 24 ] [ Designated as safety issue: No ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: . . .
Countries of Recruitment
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, France, Germany, Guatemala, Hong Kong, Israel, Japan, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Hepatitis C, Chronic

An Observational Follow-Up Study for: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium (Protocol 018) (MK-0822-083)

Recruitment Status
Completed
Project Status
Completed
Project Description
This is an observational follow-up study to Protocol 018 (A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium [1]). The objective of . . .
Primary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Study Type
Observational
Date of Registration
20 March 2014
Date of FIrst Enrollment
03 March 2014
Region
NCR
Method of Allocation
Non-randomized
Masking
Not Applicable
Assignment
Not Applicable
Phase
Not Applicable
Sources of Monetary or Material Support
Merck Sharp & Dohme (I.A.) LLC
Primary Outcomes
To collect and assess safety information for the double-blinded treatment period ending 5 years post-randomization regarding deaths, SAEs, adverse events requiring adjudication, and skin ECIs in subjects who were randomized and took at least one dose of blinded study medication, then discontinued fr . . .
Key Inclusion and Exclusion Criteria
Subject Inclusion Criteria: In order to be eligible for participation in this trial, the subject must: 1. Have been randomized into Protocol 018 2. Have taken at least 1 dose of blinded study medication 3. Have discontinued from Protocol 018 base study prior to study close-out OR have completed the . . .
Countries of Recruitment
Japan, Latvia, Lithuania, Mexico, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russia, Serbia, South Africa, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States, Poland, Portugal, Puerto Rico, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Osteoporosis

The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease

Recruitment Status
Completed
Project Status
Completed
Project Description
This is a randomized controlled, double blind trial that aims to evaluate the efficacy of methotrexate in preventing Post Molar Gestational Trophoblastic Disease (PMGTD) among patients with high-risk hydatidiform mole in our locality. Likewise, this study aims to determine the incidence of patients . . .
Primary Sponsor
Philippine General Hospital, Department of Obstetrics and Gynecology
Study Type
Interventional
Date of Registration
18 November 2013
Date of FIrst Enrollment
23 October 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind: The Patients, statistician, fellow a
Assignment
Parallel
Phase
Phase II/III
Sources of Monetary or Material Support
National Institutes of Health - University of the Philippines - Manila
Primary Outcomes
Criteria for the development for the postmolar gestational trophoblastic disease after administration of methotrexate or placebo: High level of βhCG more than 4 weeks post-evacuation (serum level of 20,000mlU/m), progressively increasing or plateauing hCG values at any time after evacuation (minimu . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Diagnosis and molar evacuation done at the Department of Obstetrics and Gynecology of the Philippine General Hospital; Patients who will undergo suction and curettage for evaluation of molar pregnancy; Histopathologically confirmed complete hydatidiform mole; Must have at least o . . .
Countries of Recruitment
Philippines, Latvia, Lithuania, Mexico, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russia, Serbia, South Africa, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States, Poland, Portugal, Puerto Rico, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Gestational trophoblastic neoplasia Hydatidiform mole

A randomized, double-blind placebo-controlled study of the maintenance of efficacy of etanercept plus DMARD(S) compared with DMARD(S) alone in subjects with rheumatoid arthritis after achieving an adequate response with Etanercept plus DMARD(S)

Recruitment Status
Completed
Project Status
Completed
Project Description
The combination of ETN 50 mg once weekly plus MTX ( other DMARDs) therapy with that of MTX ( other DMARDs) at Week 52 in subjects with moderately to severely active RA who have achieved LDA (DAS28-ESR<3.2) after 24 weeks of therapy with open-label ETN 50 mg once weekly plus MTX ( other D . . .
Primary Sponsor
Pfizer Inc.
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
15 November 2013
Date of FIrst Enrollment
14 May 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0061
Sources of Monetary or Material Support
Pfizer Inc.
Primary Outcomes
To compare the maintenance of efficacy of the combination of ETN 50 mg once weekly plus MTX ( other DMARDs) therapy with that of MTX ( other DMARDs) at Week 52 in subjects with moderately to severely active RA who have achieved LDA (DAS28-ESR<3.2) after 24 weeks of therapy with open-label E . . .
Key Inclusion and Exclusion Criteria
Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team prior to subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:  Evidence of a person . . .
Countries of Recruitment
Brazil, China, Colombia, Czech Republic, Egypt, Hungary, Jordan, Lebanon, Malaysia, Mexico, Philippines, Qatar, Romania, Russia, Saudi Arabia, South Africa, Taiwan, Thailand, Ukraine, United Arab Emirates, Poland, Portugal, Puerto Rico, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Rheumatoid Arthritis (RA)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis

Recruitment Status
Completed
Project Status
Ongoing
Project Description
This is a Phase 3, multi-centre, multi-national, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IV belimumab 10 mg/kg plus standard of care compared to placebo plus standard of care in adult subjects with active lupus nephritis. Subjects who meet the eli . . .
Primary Sponsor
Human Genome Sciences, Inc.
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
18 December 2013
Date of FIrst Enrollment
08 November 2013
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0051
Sources of Monetary or Material Support
Human Genome Sciences, Inc.
Primary Outcomes

The primary efficacy endpoint is Primary Efficacy Renal Response (PERR) at week 104

Key Inclusion and Exclusion Criteria
Diagnosis & Inclusion Criteria: Subjects enrolled in the study must meet the following inclusion criteria: 1. Males or females at least 18 years of age. . . .
Countries of Recruitment
Belgium, France, Germany, Hungary, Philippines, Spain, United Kingdom, Lebanon, Malaysia, Mexico, Philippines, Qatar, Romania, Russia, Saudi Arabia, South Africa, Taiwan, Thailand, Ukraine, United Arab Emirates, Poland, Portugal, Puerto Rico, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

active lupus nephritis


Results 91 - 100 of 541
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