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临床试验/CTRI/2025/10/095717
CTRI/2025/10/095717尚未招募不适用

Clinical Outcomes with Azelnidipine and Telmisartan Fixed-Dose Combination in Hypertensive Patients: A Real-World, retrospective Study (ACT-HTN Study)

Torrent Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2025年10月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
4,000
试验地点
1
主要终点
1. Mean change in DBP & SBP

研究概览

简要总结

This is a real-world, retrospective, observational study wherein data of patients visiting to various clinics across India will be collected. The objective of this study is to evaluate the tolerability and effectiveness of Azelnidipine/Telmisartan combination as initial-line therapy in treatment-naïve Indian adults with newly diagnosed hypertension.

The Endpoints of the study are as follows -

  1. Primary Endpoints:
  • Mean change in DBP & SBP from baseline at 12±2 weeks

2. Secondary Endpoints:

  • Proportion of patients achieving BP control (defined as mean seated SBP <130 mmHg and DBP <80 mmHg) at 12±2 weeks

  • Proportion of patients who sustained or improved on BP control achieved at 12±2 weeks over 24±2 weeks

  • Mean change in Heart Rate from baseline at 12±2 weeks

  • Incidence of adverse events

Data for approximately 4,000 patients from different sites across India will be collected for the purpose of this study.

The available data must meet all the following criteria to be included in the study:

1. Inclusion Criteria

  • Adult Male or female patients with newly diagnosed hypertension (BP >140/90 mmHg)

  • Patients diagnosed with hypertension and treated with Azelnidipine/telmisartan combination as initial line therapy

2. Exclusion Criteria

  • Patients with current or past exposure to antihypertensive medications other than study drug

Descriptive statistical analysis will be performed on all collected data and reports will be generated.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adult Male or female patients with newly diagnosed hypertension (BP more than 140/90 mmHg)
  • Patients diagnosed with hypertension and treated with Azelnidipine/telmisartan combination as initial line therapy.

排除标准

  • Patients with current or past exposure to antihypertensive medications other than study drug.

结局指标

主要结局

1. Mean change in DBP & SBP

时间窗: from baseline at 12±2 weeks

次要结局

  • 1. Proportion of patients achieving BP control (defined as mean seated SBP less than 130 mmHg and DBP less than 80 mmHg)(at 12±2 weeks)
  • 2. Proportion of patients who sustained or improved on BP control achieved at 12±2 weeks(over 24±2 weeks)
  • 3. Mean change in Heart Rate(from baseline at 12±2 weeks)
  • 4. Incidence of adverse events(at any subsequent visit post baseline)

研究者

发起方
Torrent Pharmaceuticals Ltd.
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Mukesh Gabhane

Torrent Pharmaceuticals Ltd.

研究点 (1)

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