Clinical trials: in Bulgaria
Chronic Obstructive Pulmonary Disease (COPD)
Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study
The main goal of this pharmacokinetic study in healthy volunteers is to evaluate the potential effect of cyclosporine (probe inhibitor of P glycoprotein [P-gp] and breast cancer resistance protein [BCRP] transporters) on CHF6001…
- Trial name
- DDI2 (NCT06892756)
- Testing
- CHF6001 dry powder inhaler (DPI), Cyclosporine, CHF6001 DPI
- Where
- Bulgaria
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Secondary Hyperparathyroidism, End-stage Kidney Disease (ESKD)
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases.
- Trial name
- PATH-1 (NCT05832931)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 362 people
- Sponsor
- Pathalys Pharma
Asthma
The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
Primary Objective: To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: To evaluate the effect of dupilumab at Week 24 on…
- Trial name
- VESTIGE (NCT04400318)
- Testing
- Dupilumab
- Where
- 65 sites in United States, Bulgaria and 11 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Ulcerative Colitis
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with…
- Trial name
- NCT04857112
- Testing
- Low Dose MT-1303, High Dose MT-1303, MT-1303
- Where
- 185 sites in United States, Australia and 17 more
- Volunteers
- 322 people
- Sponsor
- Bausch Health Americas, Inc.
Secondary Hyperparathyroidism, End Stage Kidney Disease
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases.
- Trial name
- PATH-2 (NCT05836220)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 412 people
- Sponsor
- Pathalys Pharma
Chronic Renal Insufficiency
Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function
The purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the…
- Trial name
- STP237 (NCT05735951)
- Testing
- STIRIPENTOL oral administration
- Where
- Bulgaria
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Biocodex
Hypercortisolism
A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with…
- Trial name
- GRADIENT (NCT04308590)
- Testing
- Relacorilant
- Where
- 45 sites in United States, Austria and 7 more
- Volunteers
- 137 people
- Sponsor
- Corcept Therapeutics
Chronic Kidney Diseases
Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)
This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage…
- Trial name
- Clarion-CKD (NCT04968184)
- Testing
- KBP-5074
- Where
- 215 sites in United States, Australia and 20 more
- Volunteers
- 652 people
- Sponsor
- KBP Biosciences
Venous Thromboembolism
A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants
The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin The secondary objectives of the…
- Trial name
- NCT05618808
- Testing
- REGN9933, Enoxaparin, Apixiban
- Where
- 16 sites in Belgium, Bulgaria and 5 more
- Volunteers
- 373 people
- Sponsor
- Regeneron Pharmaceuticals
Chronic Obstructive Pulmonary Disease (COPD)
An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.
This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.
- Trial name
- CRESCENDO (NCT05492877)
- Testing
- Mitiperstat (AZD4831)
- Where
- 101 sites in United States, Argentina and 12 more
- Volunteers
- 381 people
- Sponsor
- AstraZeneca
Neovascular Age-Related Macular Degeneration
Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD).
- Trial name
- PULSAR (NCT04423718)
- Testing
- Aflibercept High Dose VEGF Trap-Eye (BAY86-5321), Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
- Where
- 235 sites in United States, Argentina and 25 more
- Volunteers
- 1,011 people
- Sponsor
- Bayer
Heart Failure With Preserved Ejection Fraction
Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%
This is a randomised, double-blind, placebo-controlled, multi-center sequential phase 2b and Phase 3 study to evaluate the efficacy and safety of AZD4831 administered for up to 48 Weeks in participants with heart failure with…
- Trial name
- ENDEAVOR (NCT04986202)
- Testing
- AZD4831
- Where
- 171 sites in United States, Australia and 16 more
- Volunteers
- 711 people
- Sponsor
- AstraZeneca
COPD (Chronic Obstructive Pulmonary Disease)
A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a Next-Generation Propellant in Participants 40 to 80 Years of Age With COPD
The purpose of this study is to demonstrate that the lung function effect from orally inhaled BGF delivered via HFO propellant is equivalent to the lung function effect from orally inhaled BGF delivered via HFA propellant in…
- Trial name
- NCT06075095
- Testing
- BGF MDI HFO 320/14.4/9.6μg, BGF MDI HFA 320/14.4/9.6 μg
- Where
- 87 sites in United States, Argentina and 12 more
- Volunteers
- 297 people
- Sponsor
- AstraZeneca
Epithelial Ovarian Cancer, Peritoneal Cancer
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or…
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Trial name
- MIRASOL (NCT04209855)
- Testing
- Mirvetuximab Soravtansine, Paclitaxel, Topotecan
- Where
- 214 sites in United States, Australia and 19 more
- Volunteers
- 453 people
- Sponsor
- AbbVie
Heart Failure
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood…
- Trial name
- FINEARTS-HF (NCT04435626)
- Testing
- Finerenone (BAY94-8862)
- Where
- 661 sites in United States, Argentina and 35 more
- Volunteers
- 6,016 people
- Sponsor
- Bayer
Heart Failure
Emp-Activity: Empagliflozin Functional Capacity
This is a multinational non-interventional study based on newly collected data to assess demographics, disease, and treatment pattern of patients with chronic Heart Failure (HF) in a two-cohort design: one cohort will receive…
- Trial name
- NCT05350202
- Testing
- Empagliflozin
- Where
- 350 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 3,431 people
- Sponsor
- Boehringer Ingelheim
Schizophrenia
Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
- Trial name
- NCT03121586
- Testing
- Pimavanserin
- Where
- 161 sites in United States, Argentina and 12 more
- Volunteers
- 995 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
Schizophrenia
Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of negative symptoms of schizophrenia
- Trial name
- ADVANCE-2 (NCT04531982)
- Testing
- Pimavanserin
- Where
- 102 sites in Argentina, Bulgaria and 10 more
- Volunteers
- 454 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
Non-segmental Vitiligo
Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not…
- Trial name
- NCT04052425
- Testing
- Ruxolitinib cream, Vehicle
- Where
- 57 sites in United States, Bulgaria and 6 more
- Volunteers
- 330 people
- Sponsor
- Incyte Corporation
Non-segmental Vitiligo
Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not…
- Trial name
- NCT04057573
- Testing
- Ruxolitinib cream, Vehicle
- Where
- 76 sites in United States, Bulgaria and 7 more
- Volunteers
- 344 people
- Sponsor
- Incyte Corporation
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