Active controlled study design

Drug Study Designs - Information Sheet

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7/12/2018 · In these situations, active-control trials showing no difference between the new drug and control are of little value as primary evidence of effectiveness and the active-control design (the study ...

Drug Study Designs - Information Sheet

Placebo-Controlled Trials and Active-Control Trials in the ...

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9/19/2000 · This design was initially proposed by Amery as a way of avoiding extended placebo treatment of patients with angina pectoris. A particular value of the randomized withdrawal study is that it demonstrates a persistent effect for durations that would be difficult to study in placebo-controlled trials.

Placebo-Controlled Trials and Active-Control Trials in the ...

Clinical trial - Wikipedia

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Clinical study design aims to ensure the scientific validity and reproducibility of the results. ... and are designed to test simple questions or feasibility to expand the research for a more comprehensive randomized controlled trial. Active control studies ... Clinical trial costs vary depending on trial phase, type of trial, and disease ...

Clinical trial - Wikipedia

Open-label trial - Wikipedia

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An open-label trial, or open trial, is a type of clinical trial in which both the researchers and participants know which treatment is being administered. This contrasts with single blind and double blind experimental designs, where participants are not aware of what treatment they are receiving (researchers are also unaware in a double blind trial). ...

Open-label trial - Wikipedia

Efficacy and Safety of LCZ696 Compared to Valsartan, on ...

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8/12/2013 · Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction (PARAGON-HF) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Efficacy and Safety of LCZ696 Compared to Valsartan, on ...

Placebo and Active Controlled, Double Dummy Study to ...

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11/4/2011 · Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government ...

Placebo and Active Controlled, Double Dummy Study to ...

Clinical trials: active control vs placebo--what is ethical?

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The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs, superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of micro (the difference between a tested drug and comparator) < or = 0 ...

Clinical trials: active control vs placebo--what is ethical?

effect of sacubitril/valsartan compared to olmesartan on ...

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An appropriate study design is a prerequisite to reduce the potential for bias. Biases introduced by suboptimal study design cannot usually be removed during the statistical analysis phase. Therefore, the choice of an appropriate study design is at least as important, if not more important, than the approach to statistical analysis.

effect of sacubitril/valsartan compared to olmesartan on ...

Study Design Considerations - Developing a Protocol for ...

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The MANJUSRI study is going to be a randomized, open-label, active-controlled, multicenter clinic trial in which at least 3 centers will participate. The flow chart of the study is shown in Fig. 1. After randomization, all eligible AF patients in the trial are required to be treated with warfarin for at least 1 year.

Study Design Considerations - Developing a Protocol for ...

Rationale and design of MANJUSRI trial: A randomized, open ...

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Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids

Rationale and design of MANJUSRI trial: A randomized, open ...

Rationale and design of ASTEROID 2, a randomized, placebo ...

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A study design that randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied. Advantages

Rationale and design of ASTEROID 2, a randomized, placebo ...

Randomized Controlled Trial - Study Design 101

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p343 THE DESIGN OF A DOUBLE-DUMMY, ACTIVE- Method: Plasma concentrations of eslicarbazepine (main active metab- CONTROLLED, MULTINATIONAL PHASE-III NONIN- olite of ESL) and other concomitant AEDs were obtained from 641 FERIORITY TRIAL IN 900 PATIENTS WITH PARTIAL- patients receiving ESL.

Randomized Controlled Trial - Study Design 101

THE DESIGN OF A DOUBLE-DUMMY, ACTIVE-CONTROLLED ...

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Second, the non-inferiority margin for an active-controlled study is best derived from the treatment effect of the chosen active control in a placebo-controlled study in the same population of interest, and such data were available for risedronate.

THE DESIGN OF A DOUBLE-DUMMY, ACTIVE-CONTROLLED ...

Denosumab versus risedronate in glucocorticoid-induced ...

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A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: Design and rationale of the RADAR Phase IIb trial

Denosumab versus risedronate in glucocorticoid-induced ...

(PDF) A randomized, partially blinded, multicenter, active ...

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(PDF) A randomized, partially blinded, multicenter, active ...

Multicentre, randomized, open-label, two-arm parallel ...

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You recall from your wonderful learning experience in P6400 that valid controls in a case-control study are individuals that, had they acquired the disease under investigation, would have ended up as cases in your study. The best way to ensure this is to sample controls …

Multicentre, randomized, open-label, two-arm parallel ...

Epiville: Case-Control Study -- Study Design

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A Randomized Active-Controlled Study Comparing the Efficacy and Safety of Vernakalant to Amiodarone in Recent-Onset Atrial Fibrillation Objectives This randomized double-blind study compared the efficacy and safety of intravenous vernakalant and amioda- rone for the acute conversion of recent-onset atrial fibrillation (AF).

Epiville: Case-Control Study -- Study Design

A Randomized Active-Controlled Study - onlinejacc.org

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7/28/2015 · Active Smarter Kids (ASK): Rationale and design of a cluster-randomized controlled trial investigating the effects of daily physical activity on children’s academic performance and risk factors for non-communicable diseases

A Randomized Active-Controlled Study - onlinejacc.org

Active Smarter Kids (ASK): Rationale and design of a ...

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7/20/2017 · This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or ...

Active Smarter Kids (ASK): Rationale and design of a ...

A phase III, randomized, two-armed, double-blind, parallel ...

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Adaptive trial design for chronic pain: a randomized, double-blind, placebo- and active comparator (pregabalin)–controlled adaptive phase 2 study of mirogabalin (DS5565)

A phase III, randomized, two-armed, double-blind, parallel ...

Extended-release quetiapine fumarate (quetiapine XR): a ...

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7/19/2013 · This study’s objective is to demonstrate a research protocol for a randomized controlled study motivating a physically more active lifestyle based on one’s own values among physically inactive adults. The aim of the study is to evaluate the feasibility and intervention efficacy on physical activity and psychological well-being, and discuss ...

Extended-release quetiapine fumarate (quetiapine XR): a ...

Adaptive trial design for chronic pain: a randomized ...

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Adaptive trial design for chronic pain: a randomized ...

Towards a physically more active lifestyle based on one’s ...

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We have read the study design "Comparison of effects between calcium channel blocker and diuretics in combination with angiotensin II receptor blocker on 24-h central blood pressure and vascular ...

Towards a physically more active lifestyle based on one’s ...

Multicentre, randomized, open-label, two-arm parallel ...

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12/1/2005 · Study design. The base study was a 2-part, 14-week, parallel-group study which was followed by 2 consecutive, double-blind, active-comparator-controlled extensions (12 and 26 weeks, respectively). Part I of the base study was placebo-controlled; part II and …

Multicentre, randomized, open-label, two-arm parallel ...

(𝗣𝗗𝗙) Comparison of effects between calcium channel ...

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Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial

(𝗣𝗗𝗙) Comparison of effects between calcium channel ...

Etoricoxib in the treatment of osteoarthritis over 52 ...

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1/30/2009 · Much progress has occurred over the past decade in rheumatoid arthritis trial design. Recognized challenges have led to the establishment of a clear regulatory pathway to demonstrate efficacy of a new therapeutic. The use of pure placebo beyond 12 to 16 weeks has been demonstrated to be unethical and thus background therapy and/or early rescue has become regular practice.

Etoricoxib in the treatment of osteoarthritis over 52 ...

Efficacy and safety of saxagliptin in combination with ...

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Clinical Trials Study Design . ... Randomized Controlled Trials: Randomized controlled trials (RCTs) ... inactive excipients) or the active intervention. Placebo-controlled trials may be challenging to perform, particularly if the intervention involves an injection or use of a device. In addition, in cases where an established therapy is

Efficacy and safety of saxagliptin in combination with ...
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