CTRI/2022/01/039787已完成3 期
A Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative, Active-Controlled, Phase III Clinical Trial to evaluate the Efficacy and Safety of Fixed-Dose Combination of Bisoprolol 5 mg and Telmisartan 40 mg tablet versus Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and Telmisartan 40mg in subjects with mild to moderate hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 292
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female participants with age 18 years to 60 years (both inclusive) at the time of screening
- •2. Adult subjects who are capable of understanding and giving written informed consent and willing to comply with the study protocol
- •3. Subjects diagnosed with mild to moderate Essential Hypertension with SBP ranging between 140-159 mmHg and/or DBP ranging between 90- 99mmHg
- •4. Females of non-child bearing potential
- •(surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and non-pregnant & non-lactating females.
排除标准
- •1. Subjects previously sensitive to any of the ingredients of the fixed-dose combination under study or beta-blockers or angiotensin receptor blockers,
- •2. Subjects with clinically significant renal (estimated glomerular filtration rate: <30 mL/min per 1.73 m2) metabolic, hepatic, or psychiatric disorders
- •3. Subjects with hepatocellular insufficiency and in subjects with hepatic failure or active liver disease.
- •4. Subjects with a known history of secondary or malignant hypertension, severe diastolic hypertension (seated diastolic BP: >114 mm Hg)
- •5. Subjects with evidence of any cardiac arrhythmia on ECG
- •6. Any known cardiac disease/disorder in which any of the study medication is contra-indicated (e.g. severe bradycardia, heart block greater than a first degree or significant first-degree block, cardiogenic shock,decompensated cardiac failure, sick sinus syndrome without pacemaker
- •7. Subjects with known significant respiratory/liver/kidney/neurological diseases / uncontrolled diabetes,
- •8. Pregnant and lactating women or the women of child bearing age who are not practising the effective means of contraception,
- •9. Subjects otherwise judged to be inappropriate for inclusion in the study by the investigatorââ?¬•s judgment
- •10. Subjects who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug,
- •11. Subjects with known alcohol or drug abuse
- •12. Subjects with known history of HIV, Hepatitis B and Hepatitis C
研究者
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