CTRI/2016/11/007491已完成3 期
Safety and Efficacy Study of Fixed Dose Combination Tablets of Chlorthalidone, Metoprolol and Telmisartan in the treatment of Essential Hypertension with stable coronary artery disease: An Open label, Multicentric Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 254
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
- •Inclusion Criteria:
- •Subjects must meet all of the following criteria to be considered for
- •enrollment in the study:
- •1.Male or female patient aged between 18 and 65 years.
- •2.Patient of stable coronary artery disease (no change in severity of symptoms or nitrate consumption in previous 3 months)
- •3.Subject with uncontrolled essential hypertension [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 200 mmHg] who is on the stable dose of fixed drug combination therapy of Metoprolol extended release (25/50 mg) + Telmisartan 40 mg for at least 4 weeks.
- •4.As judged by the Investigator, based on a medical evaluation performed during the screening period. The medical evaluation must include normal or non-clinically significant physical examination, laboratory examination and 12-lead ECG.
- •5.Patient willing to give informed consent.
- •6.Female subjects of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study. Acceptable method of contraception includes (e.g., barrier method with spermicide). The calendar method, withdrawal, or an IUD is NOT an acceptable method.
排除标准
- •Exclusion Criteria:
- •Subjects meeting any of the following criteria must be excluded from
- •enrollment in the study:
- •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, uncontrolled thyroid disorder etc.)
- •2. Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
- •3. Presence or history of secondary or malignant hypertension.
- •4. Any known cardiac disease/disorder in which any of the study medication is contra-indicated (e.g. severe bradycardia, heart block greater than first degree or significant first degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.)
- •5. Current or recent substance abuse, including alcohol.
- •6. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.
- •7. Participation in any experimental drug study within 60 days before
- •8. Breast feeding or pregnant females or Females with child-bearing
- •potential who do not follow adequate contraceptive measures.
- •9. Concomitant or prior (within 60 days of screening) use of any of the following medications: calcium channel blocker, clonidine, aliskerin.
- •10. Subjects having intolerance, hypersensitivity or any other contraindication to any of the Investigational products.
- •11. History of HIV, Hepatitis B and Hepatitis C
- •12. Subjects judged unfit for this study by investigator.
研究者
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