CTRI/2020/12/029503尚未招募未知
A Prospective,Randomized, Open-label,Investigator initiated Study to Evaluate the Efficacy and Safety of Moxonidine tablets versus Fixed Dose Combination of Amlodipine 5 mg ,Telmisartan 40 mg & Chlorthalidone 12.5 mg Tablets in Patients with Uncontrolled Hypertension
Dr Atul Rajkondawar0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Adult male or female patients between 18 to 65 years (both ages inclusive)
- •2. Patients with uncontrolled hypertension receiving stable dose of three drug combination of Amlodipine 5 mg + Telmisartan 40 mg + Chlorthalidone 12.5 mg in a fixed dose combination for at least 6 weeks prior to randomization and who require treatment with Moxonidine based on investigatorâ??s discretion
- •3. Patients willing to give their written informed consent to participate in the study
- •4. Patients willing to comply with all aspects of the protocol
排除标准
- •1.Patients with seated systolic blood pressure more than or equal to 180 mmHg and/or diastolic blood pressure more than or equal to 110 mmHg
- •2.Patients hypersensitive to active or inactive ingredients of investigational products
- •3.Patients with uncontrolled diabetes mellitus at screening
- •4.Apparent/pseudo resistant hypertension due to white coat effect, medical inertia, poor therapeutic adherence, or history of secondary causes of hypertension
- •5.Currently receiving beta-blocker as one of the antihypertensive agents or has received beta-blocker in past 6 months prior to screening
- •6.Currently receiving or received in 6 months prior to screening alpha adrenoreceptor, imidazole receptor or any other centrally acting drugs as part of antihypertensive drug
- •7.Patients with predisposition to atrioventricular block, or known history of symptomatic hypotension or orthostatic hypotension, clinically significant electrolyte imbalance
- •8.Patients with serum creatinine more than 1.8 mg/dL
- •9.Female patients who are pregnant, lactating, or planning to become pregnant.
- •10.Female patients not willing to use acceptable method of contraception
- •11.Patients receiving tricyclic antidepressants, benzodiazepine or have received within the past month prior to screening and systemic steroids, thyroid hormones, oral contraceptives, antipsychotic drugs, nonsteroidal antiinflammatory drugs (NSAIDs), sympathomimetics, immunosuppressants, etc. have been continuously administered for more than 12 weeks prior to visit 1 (screening)
- •12.History of clinically significant hematologic, hepatic, biliary obstructive disorders, neurologic (including extra pyramidal disorder), psychiatric, renal, cardiovascular (e.g. heart failure, bradycardia [resting heart rate <50 beats per minute], severe bradyarrythmia, sick-sinus syndrome, atrioventricular block, malignant arrhythmia, severe coronary artery disease, unstable angina, vascular heart disease), endocrine, or other diseases that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses if the disease exacerbates during the study
- •13.Patients scheduled/expected to undergo surgery during the study period
- •14.Patients who have received any intervention in a clinical trial within 3 months prior to screening
- •15.Patients with history of alcohol and/or drug/substance abuse & current significant alcohol consumption which as per PI judgment, make the patient ineligible to participate in the study
研究者
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