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Clinical study protocol template

Global Clinical Development - General Medicine QAW039/fevipiprantClinical Trial protocol CQAW039A2316 / NCT03215758A 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthmaDocument type: Clinical Trial ProtocolEUDRACT number:2017-001273-16 Version number:00 (OriginalProtocol) Clinical trial phase:IIIR elease date:10- May-2017 Property of NovartisConfidentialMay not be used, divulged, published, or otherwise disclosedwithout the consent of NovartisClinical Trial protocol template Version (July 2016)NovartisConfidentialPage 2 Clinical Trial protocol (Version 00) protocol No. CQAW039A2316 Table of contentsTable of of of of of objectives and and related for study for dose/regimen, route of administration and duration of for choice ofcomparator .. and timing of interim analyses/design and and control assignment and randomization.

Document type: Clinical Trial Protocol EUDRACT number: 2017-001273-16 Version number: 00 (OriginalProtocol) Clinical trial phase:III Release date: 10-May-2017 Property of Novartis Confidential May not be used, divulged, published, or otherwise disclosed without the consent of Novartis Clinical Trial Protocol Template Version 3.2 (July 2016)

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Research Proposal - ClinicalTrials.gov

clinicaltrials.gov

as fecal microbiota transplantation (FMT). 4. Procedures Tissue samples will be obtained from consenting patients at (SDMCUT), or other relevant facilities (see section 6.i below), in accordance with protocols approved by the University of Texas Institutional Review Board (UTIRB). Patients who meet eligibility criteria will have their

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Clinical Study Report (CSR) Template (Drug and Device)

clinicaltrials.gov

ATC Anatomical Therapeutic Chemical CFB change from baseline DHA dapsone hydroxylamine eCRF electronic case report form IGA Investigator’s Global Assessment MedDRA Medication Dictionary for Regulatory Activities mITT modified intent-to-treat NAD N-acetyl dapsone PK pharmacokinetic ...

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Novartis CSR template

clinicaltrials.gov

9.1 Study design Figure 9-1 Study design BID: twice a day, QD: once a day. This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel-group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy. Approximately 200 patients were planned to be

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New antibiotic treatment options for uncomplicated ...

clinicaltrials.gov

treatment options for gonorrhoea and only a few new drugs in the development pipeline, it is important to test existing antibiotics for their efficacy in gonorrhoea treatment. Objective : This project aims to identify new treatment modalities for uncomplicated gonorrhoea using

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A PROSPECTIVE MULTI CENTER RANDOMIZED CONTROLLED …

clinicaltrials.gov

conjunction with Ceramic on Ceramic and Taperloc Complete Microplastyarticulation stem in primary total hip arthroplasty compared to patients who received the Exceed ABT Acetabular system with the same combination.

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Title: A Phase 1, Randomized, Double-Blind, Placebo ...

clinicaltrials.gov

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of TAK-653 in Healthy Subjects Phase 1 TAK-653 Escalating Single and Multiple Dose Study in Healthy Subjects Sponsor: Takeda Development Centre Europe Ltd. 61 Aldwych London, WC2B 4AE United Kingdom

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Statistical Analysis Plan (SAP) - ClinicalTrials.gov

clinicaltrials.gov

statistical analysis. The subsections below will describe analyses in addition to the descriptive statistics. 6.1 Primary outcome The primary analysis will compare intervention groups (water supplementation vs control treatment) on their mean change in fasting plasma glucose between baseline and 12 months using a linear mixed model.

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A Phase II, Randomized, Double -blind, Placebo -controlled ...

clinicaltrials.gov

• International Conference on Harmonisation, E6 Good Clinical Practice: Consolidated Guideline. • All applicable laws and regulations, including, without limitation, data privacy laws and regulations. • Regulatory requirements for reporting serious …

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DETAILED STATISTICAL ANALYSIS PLAN (SAP)

clinicaltrials.gov

Statistical principles : 4.1. Multiplicity : The diagnostic and prognostic basic stud y and each sub -study consist of one primary outcome and one or more secondary, exploratory outcomes. We will encounter multiplicity issues due to the multiple

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Title: TWILIGHT Study - Ticagrelor With Aspirin or Alone ...

clinicaltrials.gov

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EMERGENCY PROTOCOL SCENARIOS

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