Clinical Trials List
2026-06-01 - 2030-06-30
Phase III
Recruiting14
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)
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Trial Applicant
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Sponsor
ASTRAZENECA TAIWAN LIMITED
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/15
Investigators and Locations
Co-Principal Investigator
- MAO-HSIN LIN Division of Cardiovascular Diseases
- 李弘元 Division of Cardiovascular Diseases
- Tzung-Dau Wang Division of Cardiovascular Diseases
- Hsien Li Kao Division of Cardiovascular Diseases
- HUNG-JU LIN Division of Cardiovascular Diseases
- JEN-KUANG LEE Division of Cardiovascular Diseases
- 陳盈憲 Division of Cardiovascular Diseases
- CHO-KAI WU Division of Cardiovascular Diseases
- 洪啟盛 Division of Cardiovascular Diseases
- Chih-Fan Yeh Division of Cardiovascular Diseases
- 林柏志 Division of Cardiovascular Diseases
- 黃慶昌 Division of Cardiovascular Diseases
- 賀立婷 Division of Cardiovascular Diseases
- 林廷澤 Division of Cardiovascular Diseases
- 孟士瑋 Division of Cardiovascular Diseases
- 蘇乾嘉 Division of Cardiovascular Diseases
- 鄭人方 Division of Cardiovascular Diseases
- 蔡承烜 Division of Cardiovascular Diseases
- 柯宗佑 Division of Cardiovascular Diseases
- 陳俊凱 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chern-En Chiang 臨床試驗科
- Wen-Chung Yu Division of Cardiovascular Diseases
- Hao-min Cheng 教學部
- Kang-Ling Wang 臨床試驗科
- Tse-Min Lu Division of Family Medicine
- 吳承學 Division of General Internal Medicine
- 黃少嵩 Division of Family Medicine
- 黃偉銘 Division of Cardiovascular Diseases
- 張俊欽 Division of Cardiovascular Diseases
- 蔡依霖 Division of Cardiovascular Diseases
- 張皓智 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 朱志生 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
- 張建偉 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 藍偉仁 Division of Cardiovascular Diseases
- 蔡瑞鵬 Division of Cardiovascular Diseases
- 顏志軒 Division of Cardiovascular Diseases
- 林岳鴻 Division of Cardiovascular Diseases
- 余法昌 Division of Cardiovascular Diseases
- 簡世杰 Division of Cardiovascular Diseases
- 蕭智忠 Division of Cardiovascular Diseases
- 宋國慈 Division of Cardiovascular Diseases
- 黃文弘 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yung-Ta Kao Division of Cardiovascular Diseases
- Chien-Yi Hsu Division of Cardiovascular Diseases
- 洪元 Division of Cardiovascular Diseases
- 陳志維 Division of Cardiovascular Diseases
- 鄭宇倫 Division of Cardiovascular Diseases
- 陳彥舟 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉文正 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Elecoglipron
Active Ingredient
Elecoglipron
Dosage Form
錠劑
Dosage
5 mg, 15 mg, 20 mg, 45 mg
Endpoints
Inclution Criteria
Patient has lower back pain for >6 months or >18 months for pregnancy induced lower back pain
Diagnosis of the SI joint as the primary lower back pain generator based on ALL of the following: a. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and b. Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain, and c. Patient has improvement in lower back pain NRS of at least 50% of the pre injection NRS score after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test <6 months ago)
Baseline Oswestry Disability Index (ODI) score of at least 30%
Baseline lower back pain score of at least 50 on 0-100 point VAS
Patient has signed study-specific informed consent form
Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
Exclusion Criteria
Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
History of recent (<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring.
Spine surgery during the past 12 months.
Previously diagnosed or suspected osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture)
Documented osteomalacia or other metabolic bone disease
Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
Known allergy to titanium or titanium alloys
Use of medications known to have detrimental effects on bone quality and soft-tissue healing
Prominent neurologic condition that would interfere with physical therapy
Current systemic infection or local infection at the SI joint
Currently pregnant or planning pregnancy in the next year
Known or suspected drug or alcohol abuse
Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
Patient is participating in an investigational study or has been involved in an investigational study within 3 months of surgery
The Estimated Number of Participants
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Taiwan
280 participants
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Global
6950 participants
