SLCTR/2023/009招募中3 期
Efficacy and safety of GMRx2 (a single pill combination containing telmisartan/amlodipine/indapamide) compared to placebo for the treatment of hypertension: An international, multi-center, randomized, double-blind, placebo-controlled, parallel-group trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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
- •At screening visit,
- •1. Adult aged >=18 years.
- •2. Male or female
- •3. Low calculated cardiovascular risk according to local guidelines such that pharmacological blood pressure (BP) lowering treatment is not mandatory: E.g. Pooled Cohorts Equation 10-years Atherosclerotic cardiovascular disease (ASCVD) risk <10% in the United States.
- •4. Likely diagnosis of hypertension, defined as:
- •- automated Systolic blood pressure (SBP) at this clinic visit of >= 130mmHg on no BP lowering medicines or >= 120mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- •- documentation in last 6 months of office SBP >=140 mmHg and/or Diastolic
- •blood pressure (DBP) > >= 90mmHg on no BP lowering medicines or SBP>=130 and/or DBP >=85mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- •- documentation in last 6 months of home SBP .+130 mmHg and/or DBP >=80mmHg on no BP lowering medicines or SBP >=120 mmHg and/or DBP >=75mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- •- documentation in last 6 months of ambulatory daytime SBP >=130 mmHg and/or DBP >=80mmHg on no BP lowering medicines or SBP >=120 mmHg and/or DBP >=75mmHg on 1 BP lowering medicine that will be stopped at this visit.
- •5. At randomization visit,
- •1. Home SBP 130-154 mmHg.
- •2. Adherence of 80-120% to run-in medication.
- •3. Tolerated run-in medication.
- •4. Adhered to home BP monitoring schedule.
- •At week 4 (for optional Open-Label Extension Period)
- •1. Completed randomized treatment and willing to continue GMRx2-based regimen for 12 months
排除标准
- •At screening visit
- •1. Receiving 2 or more BP-lowering drugs.
- •2. Contraindication to placebo run-in or any of the trial medications.
- •At randomization visit
- •1. Contraindication to any of the randomized medications including placebo
- •At week 4 (for optional Open-Label Extension Period)
- •1. Contraindication to any of the open-label GMRx2-based BP-lowering treatment regimen.
研究者
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