Clinical trials: Circulatory; Change
Diabetic Foot Ulcers, Diabetic Foot Wounds
Wound Edge Changes Following Treatment With Santyl
The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds following 14 days of treatment with Santyl or its vehicle base.
- Trial name
- NCT01197898
- Testing
- Collagenase Santyl Ointment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Healthpoint
Carotid Artery Disease
Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure
The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in…
- Trial name
- ROADSTER (NCT01685567)
- Testing
- MICHI NPS+f
- Where
- 21 sites in United States, Spain
- Volunteers
- 219 people
- Sponsor
- Silk Road Medical
Critical Limb Ischemia, Vascular Diseases
A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia
The purpose of the study is to confirm the feasibility of study procedures and the tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)
- Conditions
- Critical Limb Ischemia, Vascular Diseases, Peripheral Arterial Disease
- Trial name
- NCT02016755
- Testing
- HGF Plasmid
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- AnGes USA, Inc.
Multiple Myeloma
A Phase I/II Study Evaluating Temferon in Multiple Myeloma Patients With Early Relapse After Front Line Therapy (TEM-MM)
This is a non-randomized, open label, phase I/II, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor…
- Trial name
- NCT03875495
- Testing
- Temferon
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- Genenta Science
Pain, Low Back Pain
Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain
The primary objective of this study is to identify the brain regions in which activity is affected by SCS. Baseline cerebral blood flow scans with the device turned off will be generated compared to scans produced with the device…
- Conditions
- Pain, Low Back Pain, Leg Pain
- Trial name
- NCT00418301
- Testing
- Precision Spinal Cord Stimulation and PET Scan
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Acute Heart Failure
Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode.
The purpose of this study was to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following…
- Trial name
- PIONEER-HF (NCT02554890)
- Testing
- sacubitril/valsartan (LCZ696), Enalapril
- Where
- 123 sites in United States
- Volunteers
- 887 people
- Sponsor
- Novartis Pharmaceuticals
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Intracerebral Hemorrhage
Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage
This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or…
- Trial name
- NCT02687191
- Testing
- PF-05230907
- Where
- 13 sites in United States, Canada and 2 more
- Volunteers
- 21 people
- Sponsor
- Pfizer
Obesity
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.
- Trial name
- NCT00603902
- Testing
- Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID)
- Where
- United States
- Volunteers
- 4,008 people
- Sponsor
- Eisai Inc.
Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic…
- Conditions
- Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction, Chronic Heart Failure, History of Chronic Heart Failure
- Trial name
- COSMIC-HF (NCT01786512)
- Testing
- Omecamtiv Mecarbil Matrix F1 Formulation, Omecamtiv Mecarbil Matrix F2 Formulation, Omecamtiv Mecarbil Swellable Core Technology F2
- Where
- 101 sites in United States, Australia and 11 more
- Volunteers
- 544 people
- Sponsor
- Cytokinetics
Bradyarrhythmia
Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient.
- Trial name
- NCT01513538
- Testing
- TherapyGuide
- Where
- France
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hereditary Angioedema
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
The study objective was to evaluate the safety and efficacy of repeat use of C1INH-nf for the treatment of acute HAE attacks.
- Trial name
- CHANGE 2 (NCT00438815)
- Testing
- C1 esterase inhibitor [human] (C1INH-nf)
- Where
- 30 sites in United States
- Volunteers
- 113 people
- Sponsor
- Shire
Hypertension, Pulmonary
Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)
The purpose of this multicentre, open label, single-arm study in approximately 20 adult patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial…
- Trial name
- NCT01462565
- Testing
- current marketed FLOLAN (epoprostenol sodium), new thermo stable formulation of epoprostenol sodium
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Obesity
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU)…
- Trial name
- NCT00603291
- Testing
- Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID)
- Where
- United States
- Volunteers
- 604 people
- Sponsor
- Eisai Inc.
Atrial Arrhythmia, QT Interval, Variation in
QT Changes as Detected From LINQ ECG During Antiarrhythmic Loading (LINQ QT)
The LINQ QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical study investigating QT interval changes due to antiarrhythmic drug loading.
- Conditions
- Atrial Arrhythmia, QT Interval, Variation in, Arrhythmias, Cardiac
- Trial name
- LINQ QT (NCT05488470)
- Testing
- LINQ/LINQ II
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure and Reduced Ejection Fraction
Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction
To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection…
- Trial name
- EVALUATE-HF (NCT02874794)
- Testing
- LCZ696 (sacubitril/valsartan), Enalapril
- Where
- 81 sites in United States
- Volunteers
- 465 people
- Sponsor
- Novartis Pharmaceuticals
Heart Valve Diseases
Medtronic HAMMOCK Post Approval Study
This study is being conducted to satisfy the post-CE approval requirement.
- Trial name
- NCT03139721
- Testing
- Mosaic model 305, model 310, and ultra model 305
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 122 people
- Sponsor
- Medtronic Cardiac Surgery
Hereditary Angioedema
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
- Trial name
- CHANGE 3 (NCT00462709)
- Testing
- C1 esterase inhibitor [human] (C1INH-nf)
- Where
- 48 sites in United States
- Volunteers
- 146 people
- Sponsor
- Shire
Diabetes Mellitus Type 2
Vildagliptin vs Sitagliptin add-on to Insulin - Impact on Glycemic Profile and Correlation of Hypoglycemic Episodes and Heart Function
Vildagliptin and Sitagliptin both belong to the class of DPP-4 inhibitors, but differ in their pharmacokinetic profile as well as in their approved application (Vildagliptin, 2x 50 mg daily, Sitagliptin, 1x 100 mg daily).
- Trial name
- CGM-VISIT (NCT01686932)
- Testing
- Vildagliptin, Sitagliptin
- Where
- 11 sites in Germany
- Volunteers
- 51 people
- Sponsor
- Novartis Pharmaceuticals
Diabetic Foot Ulcer, Peripheral Arterial Disease
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
- Conditions
- Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
- Trial name
- Dulcet (NCT05145439)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vibrato Medical, Inc.