Clinical trials: Single Layer
Heart Diseases, Cardiovascular Diseases
Trial Evaluating New Strategy in the Functional Assessment of 3-vessel Disease Using SYNTAXII Score in Patients With PCI
Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in the functional assessment of patients with new coronary 3-vessel-disease who undergo percutaneous coronary intervention (PCI)
- Conditions
- Heart Diseases, Cardiovascular Diseases, 3 Vessel Coronary Artery Disease
- Trial name
- NCT02015832
- Testing
- Coronary stent, Multi Slice Computed Tomography, instantaneous wave-free ratio
- Where
- 22 sites in Netherlands, Poland and 2 more
- Volunteers
- 454 people
- Sponsor
- ECRI bv
Healthy Volunteers
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects
Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs.
- Trial name
- NCT02963701
- Testing
- Ibuprofen, Pseudoephedrine-HCl
- Where
- South Africa
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Anti-Psychotic, Management of Manifestations of Psychotic Disorders
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.
- Conditions
- Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting
- Trial name
- NCT02943213
- Testing
- Chlorpromazine Hydrochloride
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Wound Healing
An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.
Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial-thickness.
- Trial name
- NCT01734317
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Molnlycke Health Care AB
Arthroplasties, Hip Replacement, Arthroplasties, Knee Replacement
Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty
The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as…
- Trial name
- NCT03016078
- Testing
- Mepilex Border Post-Op Ag
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Molnlycke Health Care AB
Peripheral Arterial Disease
Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
- Trial name
- ILLUMENATE (NCT01858428)
- Testing
- Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, EverCross Percutaneous Transluminal Balloon Catheter
- Where
- 44 sites in United States, Austria
- Volunteers
- 300 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular
The BIBLIOS trial investigates the efficacy and safety of BTK treatment of patients suffering from critical limb ischemia (Rutherford 5) with the Luminor-14 Paclitaxel coated Percutaneous Transluminal Angioplasty Balloon catheter…
- Trial name
- BIBLIOS (NCT03845543)
- Testing
- Luminor-14 Paclitaxel eluting balloon
- Where
- 9 sites in Belgium, Italy and 1 more
- Volunteers
- 150 people
- Sponsor
- ID3 Medical
Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products.
- Conditions
- Pressure Ulcers Stage III, Pressure Ulcer, Stage IV, Pressure Ulcer
- Trial name
- NCT03283787
- Testing
- MicroMatrix® and Cytal™ Wound Matrix 2-Layer, MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT, Negative Pressure Wound Therapy
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Integra LifeSciences Corporation
Healthy Subjects
Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet
Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet
- Trial name
- NCT03633487
- Testing
- Mucinex®
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser LLC
Atherosclerosis, Vascular Disease
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.
- Conditions
- Atherosclerosis, Vascular Disease, Arteriosclerosis
- Trial name
- LEVANT I (NCT00930813)
- Testing
- Lutonix Catheter, Standard uncoated Balloon Angioplasty Catheter
- Where
- 10 sites in Belgium, Germany
- Volunteers
- 101 people
- Sponsor
- C. R. Bard
Uterine Scar, Cesarean Section Complications
Single or Double-layer Uterine Closure Techniques
There are different surgical techniques of uterine closure during cesarean. A growing data has suggested that the closure technique has an effect on uterine scar healing.
- Conditions
- Uterine Scar, Cesarean Section Complications, Cesarean Section; Dehiscence
- Trial name
- NCT03629028
- Testing
- Residual myometrium thickness, Niche Presence, Adjacent myometrium thickness
- Where
- Turkey (Türkiye)
- Volunteers
- 282 people, healthy volunteers welcome
- Sponsor
- Safak Baran Yilmaz
Healthy Volunteers
A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet
The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men…
- Trial name
- NCT03456960
- Testing
- TAK-438ASA, TAK-438, Aspirin
- Where
- Japan
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Takeda
Helicobacter Pylori Infection
A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
This phase Ⅰb/Ⅱa, single-center, randomized, open-label study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy in asymptomatic subjects with…
- Trial name
- NCT06076681
- Testing
- TNP-2198, Rabeprazole Sodium, Amoxicillin
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics (Suzhou) Limited
Helicobacter Pylori Infection
Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
This is a single-center, randomized, open-label phase Ic/IIb clinical study to evaluate the efficacy and safety of TNP-2198 capsules, rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses…
- Trial name
- NCT06076694
- Testing
- TNP-2198, Rabeprazole Sodium, Amoxicillin
- Where
- China
- Volunteers
- 80 people
- Sponsor
- TenNor Therapeutics (Suzhou) Limited
Gastroesophageal Reflux
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.
- Trial name
- NCT00259012
- Testing
- pantoprazole sodium enteric-coated spheroid suspension
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 67 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Malignant Pleural Effusion
Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter
The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions compared to approve catheter.
- Trial name
- SWIFT (NCT02649894)
- Testing
- Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter, Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
- Where
- 19 sites in United States, United Kingdom
- Volunteers
- 119 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
ILLUMENATE Pivotal Post-Approval Study (PAS)
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate…
- Trial name
- NCT03421561
- Testing
- Stellarex 0.035" OTW Drug-coated Angioplasty Balloon, EverCross™ 0.035 PTA Balloon Catheter
- Where
- 41 sites in United States, Austria
- Volunteers
- 300 people
- Sponsor
- Spectranetics Corporation
Healthy Subjects
Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers
Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects
- Trial name
- NCT03644108
- Testing
- Mucinex® ER 600 mg
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Healthy
A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Molybdenum.
- Trial name
- NCT05319899
- Testing
- ALXN1840, Omeprazole
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Critical Limb Ischemia
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
- Trial name
- NCT01870401
- Testing
- Lutonix DCB, Uncoated PTA Catheter
- Where
- 51 sites in United States, Austria and 6 more
- Volunteers
- 442 people
- Sponsor
- C. R. Bard