CTRI/2023/09/057946 [Registered on: 22/09/2023] Trial Registered Prospectively
Last Modified On:
27/04/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A study to assess the efficacy and safety of Bempedoic Acid and Rosuvastatin Tablets in patients with lipid diorder.
Scientific Title of Study
“A Phase III, Randomized, Double Blind, Active Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Bempedoic Acid plus Rosuvastatin Tablets Versus Fixed Dose Combination of Ezetimibe plus Rosuvastatin Tablets in Patients with Hypercholesterolemia.â€
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2022/45, Version No.: 02 and Dated Apr 28, 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466,
Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Hyderabad TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466,
Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
FDC of Bempedoic Acid 180 mg plus Rosuvastatin 10 mg Tablets
Patients will be advised to take study drug orally once daily with or without food around same time every day for 12 weeks (84 days).
Intervention
FDC of Bempedoic Acid 180 mg plus Rosuvastatin 20 mg Tablets
Patients will be advised to take study drug orally once daily with or without food around same time every day for 12 weeks (84 days).
Intervention
FDC of Bempedoic Acid 180 mg plus Rosuvastatin 5 mg Tablets
Patients will be advised to take study drug orally once daily with or without food around same time every day for 12 weeks (84 days).
Comparator Agent
FDC of Ezetimibe 10 mg plus Rosuvastatin 20 mg Tablets
Patients will be advised to take study drug orally once daily with or without food around same time every day for 12 weeks (84 days).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female patients aged between 18 to 65 years (both inclusive).
2. Patients diagnosed with hypercholesterolemia defined as: LDL-C levels ≥ 100 mg/dL and ≤ 250 mg/dL.
3. Patients who are not able to tolerate the dosage of Rosuvastatin more than 20 mg.
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit.
5. Patients with no abnormality on 12-lead ECG at screening / baseline visit.
6. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
7. Patients willing to comply with the protocol requirements.
ExclusionCriteria
Details
1. Patients with total fasting (minimum of 10 hours) triglycerides (TG) ≥ 500 mg/dL at screening visit.
2. Patients with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening visit.
3. Patients with the Body Mass Index (BMI) ≥ 40 kg/m2 at screening visit.
4. Patients with uncontrolled hypertension defined as sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening visit.
5. Patients with clinically significant impaired hepatic function (SGOT & SGPT ≥ 2X the UNL and/or Total bilirubin ≥ 1.2X the UNL) at screening visit.
6. Patients with uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) >1.5X the ULN at screening visit. Patients stabilized on thyroid replacement therapy for at least 6 weeks prior to randomization are allowed.
7. Patients with creatine kinase (CK) >3X ULN at screening visit.
8. Patients with Type 1 diabetes & Type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value ≥ 9%.
9. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
10. Patients with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
11. Patient with Gastrointestinal conditions or procedures (including weight loss surgery; or gastric bypass) that may affect drug absorption.
12. Patients with history of nephritic syndrome or nephritis at screening.
13. Patients with history of hyperuricemia.
14. Patients who have a history of tendon disorders or tendon rupture.
15. Patients with any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
16. Patients with intolerance, contraindication or potential allergy/hypersensitivity to Bempedoic Acid or Ezetimibe or statins or other similar class of study drugs.
17. Patients with a history of anaemia or haemoglobinopathy and/or hemoglobin < 10 g/dL for men; hemoglobin < 9 g/dL for women at screening.
18. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
19. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
20. Patients with history of any malignancy.
21. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
22. Patients with donation or transfusion of blood, plasma, or platelets within the past 30 days prior to screening.
23. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
24. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
25. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
26. Suspected inability or unwillingness to comply with the study procedures.
27. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Percentage change in low-density lipoproteins (LDL-C) from baseline to end of the study.
At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Week 12).
Secondary Outcome
Outcome
TimePoints
Percentage change in non-HDL-C from baseline to end of the study.
At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Week 12).
Percentage change in TC from baseline to end of the study.
At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Week 12).
Percentage change in HDL-C from baseline to end of the study.
At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Week 12).
Absolute change in low density lipoproteins (LDL-C) from baseline to end of the study.
At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Week 12).
Adverse events & serious adverse events reported during the study.
Throughout the study.
Changes in clinical laboratory parameters from baseline to end of the study.
At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Week 12).
Target Sample Size
Total Sample Size="356" Sample Size from India="356" Final Enrollment numbers achieved (Total)= "397" Final Enrollment numbers achieved (India)="397"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
trial is a phase III, randomized, double blind, active controlled, prospective,
parallel group, comparative, multicentric clinical study to evaluate the
efficacy, safety and tolerability of fixed dose combination of Bempedoic Acid plus
Rosuvastatin Tablets versus fixed dose combination of Ezetimibe plus
Rosuvastatin Tablets in patients with hypercholesterolemia.
Patients
who are willing and able to participate in the study will sign and date the
Informed Consent Form on the day of screening / baseline visit (Visit 1).
During this screening period, patients who are willing to give consent will be
evaluated for all the eligibility criteria. Eligible patients (male or female) aged
between 18 to 65 years (both inclusive), diagnosed with hypercholesterolemia
defined as: LDL-C levels ≥ 100 mg/dL and ≤ 250 mg/dL and who are not able to tolerate
the dosage of Rosuvastatin more than 20 mg prior to screening will be
considered for the study.
After confirming the inclusion/exclusion criteria the
subject will be randomized and provided with study medication at randomization
visit. Subjects will be provided with patient diary at randomization visit,
which need to be brought along with in each subsequent visit till the last
visit. Follow up visits will be done on week 4/day 28(±3), week 8/day 56(±3) and
week 12/day 84(±3) (Final Visit) of treatment to assess efficacy, safety and
tolerability.
Patients will be assigned to either of the four arms
i.e., Arm A or Arm B or Arm C or Arm D consisting of FDC of Bempedoic Acid 180
mg + Rosuvastatin 5 mg Tablets or FDC of Bempedoic Acid 180 mg + Rosuvastatin
10 mg Tablets or FDC of Bempedoic Acid 180 mg + Rosuvastatin 20 mg Tablets or
FDC of Ezetimibe 10 mg + Rosuvastatin 20 mg Tablets. Patients will be advised
to take study drug orally once daily with or without food around same time
every day for 12 weeks (84 days).