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NCT ID: NCT01661634 Completed - Clinical trials for Acute Decompensated Heart Failure

Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure

TRUE-AHF
Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).

NCT ID: NCT01657162 Completed - Clinical trials for Postmenopausal Osteoporosis

Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

ACTIVExtend
Start date: November 20, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

NCT ID: NCT01656902 Completed - Clinical trials for Traumatic Articular Cartilage Defects in the Knee Joint

Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects

N3D
Start date: May 2013
Phase: Phase 3
Study type: Interventional

In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. The investigated study treatment NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure. Allocation to the study treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational product). Follow-up data for efficacy is collected for 2 years: follow-up visits are performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment; additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for implantation surgery), and blood withdrawal for safety within the first year after treatment. Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is done as substudy at specific sites only.

NCT ID: NCT01649297 Completed - Clinical trials for Diabetes Mellitus, Type 2

A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

NCT ID: NCT01638000 Completed - Urologic Diseases Clinical Trials

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

BEYOND
Start date: June 12, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

NCT ID: NCT01634152 Completed - Asthma Clinical Trials

Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.

NCT ID: NCT01634139 Completed - Asthma Clinical Trials

Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.

NCT ID: NCT01634113 Completed - Asthma Clinical Trials

Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma

Start date: July 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.

NCT ID: NCT01631214 Completed - Clinical trials for Postmenopausal Women With Osteoporosis

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

ARCH
Start date: May 4, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

NCT ID: NCT01629563 Completed - Uterine Fibroids Clinical Trials

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

PEARLIV
Start date: June 2012
Phase: Phase 3
Study type: Interventional

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.