A multicentric, randomized, prospective, double blind, parallel group, comparative, active-controlled, Phase III clinical trial to evaluate the efficacy, safety & tolerability of Fixed-Dose Combination of Bisoprolol Fumarate 5 mg, Telmisartan 40 mg and Chlorthalidone 12.5 mg Tablet versus Fixed-Dose Combination of Metoprolol Succinate ER 50 mg, Telmisartan 40 mg and Chlorthalidone 12.5 mg Tablet in patients with Uncontrolled Essential Hypertension with Stable Coronary Artery Disease (CAD).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 试验地点
- 4
研究概览
简要总结
Windlas Biotech Limited is developing a fixed dose combination of Bisoprolol Fumarate 5 mg,Telmisartan 40mg and Chlorthalidone 12.5 mg as a therapeutic option for patients with uncontrolled essential hypertension and stable coronary artery disease (CAD).Hypertension in this population often requires multi-drug therapy and this FDC aims to simplify treatment while targeting key mechanisms involved in blood pressure elevation.The Investigational product is being compared with the approved reference combination containing metoprolol succinate ER 50mg ,Telmisartan 40 mg,and Chlorthalidone 12.5 mg .
The purpose of this Phase III study is to evaluate the efficacy ,safety and tolerability of the Bisoprolol based FDC versus the Metoprolol based standard of care in adult male and female patients aged 18-65 years with uncontrolled essential hypertension on dual therapy.A total of 202 patients will be enrolled and randomised in a 1 is to 1 ration ,with an 84 day treatment period and identical dosing conditions across both arms.
It is expected that the new Bisoprolol containing FDC will demonstrate comparable blood pressure lowering effects and a similar safety profile to the reference regimen. The study endpoints have been aligned with established clinical parameters and successful outcomes will offer an additional treatment option for patients and clinicians managing high risk hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to give consent to participate
- •Female or male aged 18-65 (both inclusive) years at the time of consent.
- •Patients must have uncontrolled essential hypertension with stable coronary artery disease (CAD) having mean seated SBP less than 140 to 179 and DBP of less than 90 to 109 mmHg despite being on a stable regimen of dual anti-hypertensive for at least 4 weeks prior to study entry.
- •Must demonstrate a mean seated SBP less than 140-179 and DBP less than 90-109 mmHg; [Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit].
- •Have no change in background therapy regimen and dose consisting of a stable regimen of dual anti-hypertensive agents including a beta-blocker such as Bisoprolol Fumarate 5 mg (or equivalent dose of any other beta blocker) for at least 4 weeks prior to study entry (participants who do not meet this criterion may be rescreened at the Investigator’s discretion).
- •In case of females, non-child bearing potential (surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and nonpregnant & non-lactating females having a negative serum/urine pregnancy test.
排除标准
- •Patient will be excluded if any exclusion criteria listed below are met:
- •Has a mean seated SBP more than 180 mmHg or DBP more than 110 mmHg at Screening; [Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit.]
- •Body mass index less than 40 kg^m2 at Screening;
- •Patients previously sensitive to any of the ingredients of the investigational products.
- •Patients with a known history of secondary or malignant hypertension.
- •New York Heart Association (NYHA) class IV Congestive Heart Failure.
- •MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
- •Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization.
- •Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement.
- •Active malignancy requiring treatment at the time of visit
- •Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT]less than 3x the upper limit of normal [ULN]; or total bilirubin less than 2x ULN at time of enrolment).
- •Abnormal Serum Potassium (K+ equal to 3.5 to 5.1 mmol^L).
- •Abnormal TSH value at screening.
- •Type 1 Diabetes Mellitus or uncontrolled Type 2 DM (HbA1c more than 9.5 percent).
- •Patients otherwise judged to be inappropriate for inclusion in the study by the investigator’s judgment.
- •Patients with known alcohol or drug abuse history.
- •Patients with known History of HIV, Hepatitis B and C.
- •Known history of blood-borne diseases.
- •Women of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
- •Participation in another clinical study with an IP during the last month prior to enrolment.
- •Inability of the patient, in the opinion of the investigator, to understand and/or comply with IP, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
研究者
Mr Kartik Sahni
Insignia Clinical Services