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NCT ID: NCT01880424 Completed - Clinical trials for Irritable Bowel Syndrome With Constipation (IBS-C)

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

D5630C00001
Start date: July 2013
Phase: Phase 3
Study type: Interventional

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand. The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).

NCT ID: NCT01876420 Completed - Aortic Stenosis Clinical Trials

The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study

Start date: October 2013
Phase: N/A
Study type: Interventional

To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.

NCT ID: NCT01868061 Completed - Asthma Clinical Trials

A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

NCT ID: NCT01867125 Completed - Asthma Clinical Trials

A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

NCT ID: NCT01857206 Completed - Influenza Clinical Trials

Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Start date: May 2013
Phase: Phase 3
Study type: Interventional

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

NCT ID: NCT01855997 Completed - Clinical trials for Hepatitis B, Chronic

A Study to Collect Blood Biomarker Samples From Patients With Chronic Hepatitis B Who Received Treatment With Pegasys (Peginterferon Alfa-2a) +/- Nucleos(t)Ide Analogue

Start date: August 2013
Phase: N/A
Study type: Observational

This phase 4 study is designed for the collection of blood biomarker samples from patients who have completed chronic hepatitis B treatment with at least 25 weeks of a Pegasys (peginterferon alfa 2a) containing regimen and at least 24 weeks post-treatment follow-up. Patients may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche or from general medical practice. The follow-up of patients who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. Data from whole blood DNA samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies. Procedures will include blood sample collection (not applicable for patients who previously have consented and donated RCR DNA samples) and medical record capture.

NCT ID: NCT01854918 Completed - Clinical trials for Hyperlipidemia and Mixed Dyslipidemia

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

OSLER-2
Start date: April 23, 2013
Phase: Phase 3
Study type: Interventional

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

NCT ID: NCT01854645 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.

NCT ID: NCT01854047 Completed - Asthma Clinical Trials

An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Start date: June 2013
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma Secondary Objective: To evaluate different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma, with regard to: - Safety and tolerability - Dupilumab systemic exposure and anti-drug antibodies

NCT ID: NCT01851824 Completed - Clinical trials for Malignant Melanoma, Neoplasms

A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

Start date: August 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26, eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (GO28399 [NCT01739764]).