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NCT06500689CompletedPhase 3

To Assess Allisartan Isoproxil/Sustained-Release Indapamide in Patients With Essential Hypertension Uncontrolled With Allisartan Isoproxil

Efficacy and Safety of Allisartan Isoproxil/Sustained-Release Indapamide in Patients With Essential Hypertension Uncontrolled With Allisartan Isoproxil: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study

Source: ClinicalTrials.gov · Last updated 15 Jul 2024

Brief summary (registry, in English)

The main objective of the study will be to assess the efficacy and safety of Allisartan Isoproxil/sustained-release indapamide (240 mg/1.5 mg) in patients with mild to moderate essential hypertension uncontrolled after 4-week treatment with Allisartan Isoproxil (240 mg).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
366 (actual)
First submitted
8 Jul 2024
Start date
30 Dec 2021
Primary completion date
27 Nov 2023
Lead sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
NCT number
NCT06500689

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 366
  • From 30 Dec 2021 to the primary completion date, 27 Nov 2023
  • 40 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have taken three or more antihypertensive drugs (including single-pill combination) simultaneously within one month prior to screening.

Other illness

  • Patients with secondary hypertension;
  • Patients with history of heart failure (New York Heart Association (NYHA) Functional Classification class III and IV), acute coronary syndrome, percutaneous coronary intervention, or other serious heart diseases (such as cardiogenic shock, moderate or severe heart valvular disorders, atrioventricular block second or third degree, bradycardia (with a heart rate \<50 beats per minute), severe arrhythmias) in the past 6 months.
  • Patients with history of severe cerebrovascular diseases (such as hypertensive encephalopathy, cerebrovascular injury, stroke, transient ischemic attack) in the past 6 months.
  • Patients with severe renal insufficiency (Cr\>1.5 times the upper limit of normal).

Other

  • Patients with msSBP ≥180 m mHg and/or msDBP≥110 mmHg, or withhypertensive emergency or hypertensive urgency.
  • Patients with aortic aneurysm, aortic dissection, or dissecting aneurysm.
  • Patients with hypokalemia or hyperkalemia.

Who the study is looking for

  • Patients 18-75 years old with mild to moderate essential hypertension;
  • Patients who meet one of the following criteria when screening:
    • Untreated patients (either newly diagnosed essential hypertension or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 2 weeks before the first visit) must have an office msSBP ≥ 150 mmHg and \< 180 mmHg and msDBP\<110 mmHg;
    • Patients who had not received regular treatment with allisartan isoproxil (240 mg/day) (less than 4 weeks of medication intake or a history of missing doses for 5 or more days within the 4 weeks before screening) with the msSBP of 140 mmHg≤ SBP \<180 mmHg and DBP\<110 mmHg;
    • Patients currently receiving other antihypertensive agents (non-study medications for at least 2 weeks prior to screening) with the msSBP of 140 mmHg≤ SBP \<180 mmHg and DBP\<110 mmHg, and the clinician determined that it was appropriate to switch to allisartan isoproxil (240 mg/day);
    • Patients who have been stably treated with allisartan isoproxil (240 mg/day) for at least 4 weeks with the msSBP of 140 mmHg≤ SBP \<180 mmHg and DBP\<110 mmHg.
  • During randomization for the double-blind treatment period, msSBP should be 140 mmHg≤ SBP \<180 mmHg and DBP\<110 mmHg;
  • Participants enrolled in the ABPM study should have 24-hour mean ambulatory blood pressure ≥130/80 mmHg after 4 weeks of monotherapy treatment;
  • Patients who understand and sign the informed consent form.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aerospace Central Hospital
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BeijingChinaUnknown status
China-Japan Friendship Hospital
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BeijingChinaUnknown status
The First Affiliated Hospital of Bengbu Medical College
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BengbuChinaUnknown status
Xiangya Second Hospital of Central South University
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ChangshaChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Chongqing University Affiliated Three Gorges Hospital
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ChongqingChinaUnknown status
Daqing People's Hospital
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DaqingChinaUnknown status
Shunde Hospital of Southern Medical University
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FoshanChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Ganzhou People's Hospital
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GanzhouChinaUnknown status
The First Affiliated Hospital of Gannan Medical College
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GanzhouChinaUnknown status
Huai'an First People's Hospital
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Huai'anChinaUnknown status
Kaifeng Traditional Chinese Medicine Hospital
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KaifengChinaUnknown status
The Second Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Gansu Provincial People's Hospital
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LanzhouChinaUnknown status
Nanchong Central Hospital
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NanchongChinaUnknown status
Nanning First People's Hospital
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NanningChinaUnknown status
Li Huili Hospital of Ningbo Medical Center
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NingboChinaUnknown status
Pingxiang People's Hospital
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PingxiangChinaUnknown status
Quzhou people's Hospital
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QuzhouChinaUnknown status
The Fourth Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Hebei Provincial People's Hospital
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ShijiazhuangChinaUnknown status
Shijiazhuang People's Hospital
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ShijiazhuangChinaUnknown status
The Third Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Chinese Medicine Dongfeng General Hospital
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ShiyanChinaUnknown status
Suining Central Hospital
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SuiningChinaUnknown status
Suzhou Municipal Hospital
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SuzhouChinaUnknown status
The Second Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Tonghua Central Hospital
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TonghuaChinaUnknown status
Wenzhou Medical University Affiliated First Hospital
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WenzhouChinaUnknown status
Wuhan First Hospital
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WuhanChinaUnknown status
Wuhan Sixth Hospital
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WuhanChinaUnknown status
Wuhan Fourth Hospital
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WuhanChinaUnknown status
Shanxi Provincial People's Hospital
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Xi’anChinaUnknown status
Xuancheng People´s Hospital
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XuanchengChinaUnknown status
Xuzhou Central Hospital
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XuzhouChinaUnknown status
Yueyang Central Hospital
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YueyangChinaUnknown status
Yueyang People's Hospital
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YueyangChinaUnknown status
Guangdong Medical University Affiliated Hospital
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ZhanjiangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.