CTRI/2009/091/000287招募中4 期
A randomized, single-blind, parallel group, multiple oraldose study to evaluate the effect of a light meal on thepharmacokinetics and pharmacodynamics of aliskirenusing market 300 mg tablet formulation in subjects withmild to moderate hypertension
ovartis Healthcare Pvt. Ltd.0 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
- 招募中
- 发起方
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
- •1. Male and female out-Subjects aged 18 to 65 years.
- •2. Subjects with a diagnosis of mild to moderate essential hypertension:
- •Subjects who are newly diagnosed with hypertension or Subjects who have not received anti-hypertensive medication for at least 2 weeks prior to Visit 1 have to have a mean sitting diastolic blood pressure (msDBP) ≥ 95 and < 110 mmHg and mean sitting systolic blood pressure (msSBP) < 180 mmHg at Visit 1/Visit 3 and at Visit 6.
- •? Subjects with history of hypertension and on current antihypertensive medication at Visit 1 have to have a msDBP < 110 mmHg at Visit 1 and a msDBP ≥ 95 and < 110
- •mmHg and a msSBP < 180 mm Hg at Visit 3 and at Visit 6.
- •3. Female Subjects must be of non-child bearing potential defined as postmenopausal females with no regular menstrual bleeding for at least 1 year prior to inclusion (Menopause will be confirmed by a plasma FSH level of >40 IU/L), OR female subjects surgically sterilized at least 6 months prior to screening (Surgical Sterilization procedures must be supported with clinical documentation made available to sponsor and noted in the
- •Relevant Medical History / Current Medical Conditions section of the CRF). All female subjects must have negative pregnancy results at screening and baseline Day -2 (regardless of reported reproductive status).
- •4. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges.
- •5. Mild smokers (use of less than 10 cigarettes or beedies per day) will be allowed participation, provided they are willing to discontinue during the PK/PD sampling in the trial.
- •6. Subjects who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
排除标准
- •Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
- •History or evidence of a secondary form of hypertension [renal, endocrine origin, etc.]
- •Inability to discontinue all prior anti-hypertensive medications safely before placebo runin period
- •History of severe hypersensitivity or contraindications to study drug or a drugs belonging to the similar therapeutic class (ARB, Angiotensin-converting-enzyme inhibitor (ACEs),
- •aliskiren) as the study drug, including a history of angioedema.
- •Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or plasma up to 7 days prior to randomization.
- •Use of other investigational drugs at the time of enrollment (Visit 1), or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •History of immunodeficiency diseases, including a positive HIV (As per local guidance).
- •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (As per local guidance).
- •Any surgical or medical condition which in the opinion of the investigator may place the Subject at higher risk from his/her participation in the study, or is likely to prevent the
- •Subject from complying with the requirements of the study or completing the study.
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •Subjects who have been previously (within 3 months of Visit 1) been treated with aliskiren
- •Nursing (lactating) women.
研究者
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