CTRI/2023/03/051014进行中（未招募）4 期
A Prospective, Open label, Randomized, Multicenter, Post marketing study comparingEffectiveness and Safety of Telmisartan plus Amlodipine with Telmisartan plus Cilnidipine insubjects with Hypertension and Renal Impairment.
Glenmark Pharmaceuticals Ltd0 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
- 4 期
- 状态
- 进行中（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
- Observational
入排标准
入选标准
- •1. Male or female subjects aged between 18 to 75 years
- •2. Subjects with the ability to understand and provide written informed consent forms which must have been obtained prior to screening.
- •3. Subjects with hypertension (systolic/diastolic BP more than or equal to 130/80 and less than 180/110 mmHg
- •4. Subjects with hypertension and renal impairment eGFR more than or equal to 60 ml/min/1.73m2 and
- •urinary albumin in the range of 30â??600 mg/g creatinine
- •5. Subjects with hypertension requiring antihypertensive treatment with two drug
- •6. Subjects on a stable dose of antihypertensive treatment with Telmisartan for more than or equal to 3 months before the enrolment;
- •7. Subjects not on CCB treatment for their hypertension management for more than or equal to 3 months before the enrolment
- •8. Subjects willing to comply with the protocol requirements
排除标准
- •1. Presence of any clinically relevant disease/disorder (e.g., severe hepatic
- •impairment, chronic renal failure, thromboembolic disorders, coronary artery or
- •cerebrovascular diseases, uncontrolled diabetes (HbA1c more than or equal to 7%), uncontrolled thyroid
- •disorder etc.)
- •2. Causes of renal disease other than hypertension or T2DM
- •3. Urinary tract infections
- •4. Acute Kidney Injury (AKI)
- •5. Subjects of T1DM
- •6. Subjects of T2DM diagnosed more than 1 year prior to screening
- •7. Severe hypertension (more than or equal to 180/110 mmHg)
- •8. Serum creatinine more than or equal to 2.0 mg/dL in men or more than or equal to1.5 mg/dL in women
- •9. Subjects, in the opinion of investigators, requiring initiation of treatment with initial
- •monotherapy
- •10. Surgical or medical condition that, in the judgment of the Investigator, could
- •interfere with the absorption, distribution, metabolism, or excretion of the drugs to be
- •11. Presence or history of secondary or malignant hypertension.
- •12. Any known cardiac disease/disorder in which any of the study medications is
- •contra-indicated.
- •13. Current or recent substance abuse, including alcohol.
- •14. Refusal or inability to comply with the requirements of the protocol for any
- •the reason, including scheduled clinic visits and laboratory tests.
- •15. Participation in any experimental drug study within 60 days before screening.
- •16. Breast feeding or pregnant females or Females with child-bearing potential who
- •do not follow adequate contraceptive measures.
- •17. Concomitant or prior (within 60 days of screening) use of any of the following
- •medications: calcium channel blocker, clonidine, aliskerin.
- •18. Subjects having intolerance, hypersensitivity or any other contraindication to
- •any of the Investigational products.
- •19. History of HIV, Hepatitis B and Hepatitis C.
研究者
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