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.
- Diseases
- High blood pressure
- 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
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aerospace Central Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| Xiangya Second Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing University Affiliated Three Gorges Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Daqing People's Hospital Coordinator of this site? Confirm its status | Daqing | China | Unknown status |
| Shunde Hospital of Southern Medical University Coordinator of this site? Confirm its status | Foshan | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Ganzhou People's Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| The First Affiliated Hospital of Gannan Medical College Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Huai'an First People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Unknown status |
| Kaifeng Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Kaifeng | China | Unknown status |
| The Second Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Gansu Provincial People's Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Nanchong Central Hospital Coordinator of this site? Confirm its status | Nanchong | China | Unknown status |
| Nanning First People's Hospital Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Li Huili Hospital of Ningbo Medical Center Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| Quzhou people's Hospital Coordinator of this site? Confirm its status | Quzhou | China | Unknown status |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Hebei Provincial People's Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Shijiazhuang People's Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| The Third Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Chinese Medicine Dongfeng General Hospital Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| Suining Central Hospital Coordinator of this site? Confirm its status | Suining | China | Unknown status |
| Suzhou Municipal Hospital Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| The Second Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tonghua Central Hospital Coordinator of this site? Confirm its status | Tonghua | China | Unknown status |
| Wenzhou Medical University Affiliated First Hospital Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Wuhan First Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuhan Sixth Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuhan Fourth Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Shanxi Provincial People's Hospital Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Xuancheng People´s Hospital Coordinator of this site? Confirm its status | Xuancheng | China | Unknown status |
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Yueyang Central Hospital Coordinator of this site? Confirm its status | Yueyang | China | Unknown status |
| Yueyang People's Hospital Coordinator of this site? Confirm its status | Yueyang | China | Unknown status |
| Guangdong Medical University Affiliated Hospital Coordinator of this site? Confirm its status | Zhanjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.