A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects with Stage 2 Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 12
- 主要终点
- To evaluate the efficacy and safety of Fixed Dose Combination (FDC) of Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects with Stage 2 Hypertension
研究概览
简要总结
A Multicentric, Randomized, Double Blind, Parallel Group,Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety andTolerability of Fixed Dose Combination (FDC) of Efonidipine HydrochlorideEthanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets andEfonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate ExtendedRelease 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mgand Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjectswith Stage 2 Hypertension
PrimaryObjective
· To evaluate the efficacyand safety of Fixed Dose Combination (FDC) of Efonidipine HydrochlorideEthanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets andEfonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate ExtendedRelease 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mgand Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjectswith Stage 2 Hypertension.
SecondaryObjective
· To evaluate thetolerability of Fixed Dose Combination (FDC) of Efonidipine HydrochlorideEthanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets andEfonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate ExtendedRelease 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mgand Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjectswith Stage 2 Hypertension.
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
- •Subjects meeting all of the following criteria will be recruited for the trial: 1.Male or Female subjects between 18 to 65 years of age (both inclusive).
- •2.Treatment-Naïve subjects who are suffering from Stage 2 Hypertension.
- •3.Subjects diagnosed with mean SBP of more than 160 to less than 180 mmHg and mean DBP more than 100 to less than 110 mmHg (3 readings will be taken by validated automated blood pressure machine in sitting position, first reading will be taken after 15 min.
- •rest and subsequent two readings will be recorded at the interval of 2 min.
- •4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Subjects will be excluded if ANY of the following conditions apply: 1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •2.Subjects with known case of Secondary or Malignant Hypertension.
- •3.Subjects with abnormal Renal Function Test.
- •4.Subjects with abnormal eGFR will be excluded from the study.
- •5.Subjects with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one functioning kidney.
- •6.Subjects with hyponatremia.
- •7.Subjects with abnormal Liver Function Tests.
- •8.Subjects with abnormal Thyroid Function Test.
- •9.Subjects with known case of Type 1 Diabetes Mellitus will be excluded from the study.
- •10.Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8% will be excluded from the study.
- •11.Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias.
- •12.Subjects with known case of Stroke.
- •13.Subject with clinical history of Bronchospastic disorders.
- •14.Subjects with medical history of Oncological Conditions since last 2 years.
- •15.Subjects with known case of Epileptic seizures.
- •16.Subjects with clinical history of bipolar disorder i.e. who are taking lithium.
- •17.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
- •18.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •19.Currently taking prohibited concomitant medications listed and inability/unwillingness to discontinue them for the entire study period.
- •20.Suspected inability or unwillingness to comply with the study procedures.
- •21.Subjects with abnormal Serum potassium.
结局指标
主要结局
To evaluate the efficacy and safety of Fixed Dose Combination (FDC) of Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects with Stage 2 Hypertension
时间窗: Change from baseline in mean sitting SBP to the end of study (12 weeks)
次要结局
- To evaluate the tolerability of Fixed Dose Combination (FDC) of Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects with Stage 2 Hypertension(Change from baseline in mean sitting DBP to the end of study (12 weeks))