18 studies found for:    u.s. pivotal trial
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Rank Status Study
1 Active, not recruiting
Has Results
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
Condition: Severe Aortic Stenosis
Interventions: Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI);   Device: Surgical Aortic Valve Replacement (SAVR)
2 Completed
Has Results
Esteem Totally Implantable Hearing System
Condition: Mild to Severe Sensorineural Hearing Loss
Intervention: Device: Esteem Totally Implantable Hearing System
3 Active, not recruiting Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
Condition: Peripheral Arterial Disease
Interventions: Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter;   Device: EverCross Percutaneous Transluminal Balloon Catheter
4 Completed Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
Condition: Skin Diseases
5 Completed
Has Results
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
Condition: Coronary Artery Disease
Intervention: Device: Diamondback 360 Orbital Atherectomy System
6 Completed Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
Condition: Cutaneous Leishmaniasis
Interventions: Drug: WR 279,396;   Drug: Paromomycin
7 Recruiting A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
Conditions: Congenital Bleeding Disorder;   Haemophilia A
Intervention: Drug: turoctocog alfa pegol
8 Completed Hepatic Monitoring for Pazopanib
Condition: Carcinoma, Renal Cell
Interventions: Drug: Pazopanib use;   Drug: Use of sunitinib, bevacizumab, or sorafenib
9 Completed
Has Results
Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
Intervention: Drug: Pazopanib plus capecitabine
10 Terminated A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain
Condition: Postoperative Pain
Interventions: Drug: Intravenous ibuprofen;   Drug: Saline solution
11 Terminated Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
Interventions: Drug: DP-b99;   Drug: Placebo
12 Recruiting Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Allergic Asthma
Condition: Allergic Asthma
Interventions: Device: CREON2000A;   Device: Sham
13 Completed Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD
Conditions: Diabetes Mellitus;   Asthma;   Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Human Insulin Inhalation Powder;   Drug: injected insulin
14 Active, not recruiting Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)
Conditions: Chronic Myeloid Leukemia;   Ph+ Acute Lymphoblastic Leukemia
Intervention: Drug: Ponatinib
15 Completed Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
Intervention: Drug: Desvenlafaxine Succinate
16 Completed Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone (OPAL)
Condition: Opioid-induced Bowel Dysfunction
Interventions: Drug: Lubiprostone;   Drug: Placebo
17 Terminated
Has Results
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
Condition: Back Pain Lower Back Chronic
Intervention: Drug: Buprenorphine transdermal patch
18 Completed
Has Results
A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis
Interventions: Drug: SD-6010;   Drug: Placebo

Study has passed its completion date and status has not been verified in more than two years.