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
- 264
- 试验地点
- 9
- 主要终点
- Percentage of the subjects achieved the target levels of clinical BP among mild to moderate hypertensive subjects (target level: SBP less than 140 mm Hg and DBP less than 90 mm Hg)
研究概览
简要总结
In India, Bisoprolol and Telmisartan are already approved and marketed. Therefore, considering the unmetneed for an FDC and based on regulatory requirement M/s. WindlasBiotech Ltd. proposes the present study be conducted to generatedata on the Indianpopulation.The studydesign is a multi-centre study to evaluate efficacyand safety of fixed-dose combination (FDC)ofBisoprolol 5 mg and Telmisartan 40 mg tabletin subjects with mild to moderatehypertension. The purpose of the present study is to demonstrate that a fixed-dose combination (FDC) of Bisoprolol5 mgand Telmisartan 40mg tablet is efficacious and safe in Indian subjects with regard to the routine clinicalsetting.
This will be a multicentre, randomized, double-blind, parallel-Group, comparative active-controlled phase III clinical trial to evaluate the efficacyand safety of fixed-Dose Combination of Bisoprolol 5 mg andTelmisartan 40mg tabletversus a fixed-Dose combination of Metoprolol Succinate ER 50 mg and Telmisartan40 mgtablets in subjects with mildto moderatehypertension. Initially, subjects willbe screened asper predefinedeligibility criteria for thestudy. The ITT population will include approximately a total number of 264 eligible male and female patients of any ethnicity diagnosed with mild to moderate hypertension. Eligible264 subjects will be either enrolled to receive Fixed-Dose Combination (FDC) of Bisoprolol 5mg and Telmisartan 40mgtablet or Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and Telmisartan 40 mg tablets in 1:1 ratio.
**Test Arm:**Treatment Arm 1: Fixed-Dose Combination (FDC) of Bisoprolol 5 mg and Telmisartan 40 mg tablet (n=132)
**Reference Arm:**Treatment Arm 2: Fixed-Dose Combination of Metoprolol SuccinateER 50 mg and Telmisartan 40 mg (n=132)
Efficacy:
Primary endpoint
· Percentage of the subjects achieved the target levels of clinical BPamong mild to moderate hypertensive subjects (target level: SBP < 140 mm Hg and DBP <90mm Hg);
Secondar****y endpoint
· Mean reduction in systolicand diastolic blood pressuremeasured in sittingpositioncompared tobaseline (After 4,8 and 12 weeks)
· Proportion of responders after12 weeks of dosing (Responder ratedefined as the proportion of subjects with a decrease in diastolic BP by atleast 10 mmHg).
· Reduction in mean heart rate compared to baseline (After 4, 8 and 12weeks)
Safety (Screeningvisitto end of study visit)
· Adverse Events (AE) assessment
· Physical& systemic examination
· Vital signs
. Lab abnormalities
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Male or female participants with age 18 years to 60 years (both inclusive) at the time of screening
- •Adult subjects who are capable of understanding and giving written informed consent and willing to comply with the study protocol
- •Subjects diagnosed with mild to moderate Essential Hypertension with SBP ranging between 140-159 mmHg and/or DBP ranging between 90- 99mmHg
- •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
- •Subjects previously sensitive to any of the ingredients of the fixed-dose combination under study or beta-blockers or angiotensin receptor blockers,
- •Subjects with clinically significant renal (estimated glomerular filtration rate: <30 mL/min per 1.73 m2) metabolic, hepatic, or psychiatric disorders
- •Subjects with hepatocellular insufficiency and in subjects with hepatic failure or active liver disease.
- •Subjects with a known history of secondary or malignant hypertension, severe diastolic hypertension (seated diastolic BP: >114 mm Hg)
- •Subjects with evidence of any cardiac arrhythmia on ECG
- •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 etc.)
- •Subjects with known significant respiratory/liver/kidney/neurological diseases / uncontrolled diabetes,
- •Pregnant and lactating women or the women of child bearing age who are not practising the effective means of contraception,
- •Subjects otherwise judged to be inappropriate for inclusion in the study by the investigator’s judgment
- •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,
- •Subjects with known alcohol or drug abuse
- •Subjects with known history of HIV, Hepatitis B and Hepatitis C.
结局指标
主要结局
Percentage of the subjects achieved the target levels of clinical BP among mild to moderate hypertensive subjects (target level: SBP less than 140 mm Hg and DBP less than 90 mm Hg)
时间窗: 12 weeks
次要结局
- Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline(4, 8 and 12 weeks)
- Proportion of responders after 12 weeks of dosing (Responder rate defined as the proportion of subjects with a decrease in diastolic BP by at least 10 mmHg).(12 weeks)
- Reduction in mean heart rate compared to baseline(4, 8 and 12 weeks)
- Adverse Events assessment, Physical and systemic examination, Vital signs, Lab abnormalities(4, 8 and 12 weeks)