NCT07181109ClinicalTrials.gov
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
בקצרה
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the…
שלב 3דרושים 11,000 משתתפים1,153 אתרים35 מדינות
קטגוריות
רשום במרשם אחד
- ClinicalTrials.govNCT07181109פתיחת רשומה זו ב־ClinicalTrials.govסונכרן שלשום
מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.
מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.
מתעניינים במחקר הזה?
התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.
How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2025-09-18; recorded start 2025-09-22
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Present: Uses blinding (masking)A masking level is recorded in the record
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 50 other studies in this databaseCounted from the lead sponsor named in the record (Alnylam Pharmaceuticals)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 3 conditions.
- Lead sponsor type recorded as: industry.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding20/20
Quadruple-blind
- Control arm13/15
Placebo / sham control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
- Multi-centre8/8
Multi-centre: 995 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A very large study, international in scope: 11,000 participants (target), run at 1,153 sites, across 35 countries.
How this score is built
- Enrolment38/40
11,000 participants (target)
- Site count25/25
995 sites
- Country count15/15
34 countries
- Planned duration10/10
Planned over about 61 months
- Sponsor scale6/10
Alnylam Pharmaceuticals has led 53 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
תקציר
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
מצבים רפואיים
- High Risk Cardiovascular Disease
- Hypertension
- High Cardiovascular Risk
זכאות
| מין | הכול |
|---|---|
| גילאים | 18 Years – ללא מקסימום |
| מתנדבים בריאים | לא |
זכאות כפי שנכתבה במרשם
זכאות במשפטים פשוטים
הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.
תכנון המחקר
| סוג המחקר | התערבותי |
|---|---|
| שלב | שלב 3 |
| הקצאה | אקראי |
| מודל ההתערבות | PARALLEL |
| מטרה ראשית | TREATMENT |
| הסתרה | QUADRUPLE (4) |
| גיוס | דרושים 11,000 משתתפים |
נותן חסות ושותפים
- Alnylam Pharmaceuticals נותן חסות
- Hoffmann-La Roche שותפים
זרועות והתערבויות
- Zilebesiran 300 mgEXPERIMENTAL
Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.
- PlaceboPLACEBO_COMPARATOR
Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.
התערבויות
- תרופה Placebo
Placebo will be administered SC
- תרופה Zilebesiran
Zilebesiran will be administered SC
מדדי תוצאה
מדד תוצאה ראשוני
Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)
מסגרת זמן Up to approximately 5 years
מדד תוצאה משני
Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6
מסגרת זמן Baseline and Month 6
מדד תוצאה משני
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke
מסגרת זמן Up to approximately 5 years
מדד תוצאה משני
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)
מסגרת זמן Up to approximately 5 years
מדד תוצאה משני
Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization
מסגרת זמן Up to approximately 5 years
מדד תוצאה משני
Time to All-cause Death
מסגרת זמן Up to approximately 5 years
תאריכים
| תאריך התחלה | 22 בספטמבר 2025 (בפועל) |
|---|---|
| סיום ראשוני | 23 בספטמבר 2030 (משוער) |
| סיום | 23 בספטמבר 2030 (משוער) |
| פורסם לראשונה | 18 בספטמבר 2025 (בפועל) |
| עודכן לאחרונה | 18 בספטמבר 2026 |
| התוצאות פורסמו | לא צוין ברשומת המרשם |
| המצב אומת לאחרונה | ספטמבר 2026 |
בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.
מיקומים
922 אתרים מגייסים
Argentina
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Clinical Trial Site | Bahía Blanca | מגייס | |
| Clinical Trial Site | Bahía Blanca | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | טרם מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Buenos Aires | מגייס | |
| Clinical Trial Site | Ciudadela | מגייס | |
| Clinical Trial Site | Coronel Suárez | מגייס | |
| Clinical Trial Site | Corrientes | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Córdoba | מגייס | |
| Clinical Trial Site | Esperanza | מגייס | |
| Clinical Trial Site | Formosa | מגייס | |
| Clinical Trial Site | General San Martín | מגייס | |
| Clinical Trial Site | Granadero Baigorria | מגייס | |
| Clinical Trial Site | Lanús Este | מגייס | |
| Clinical Trial Site | Mar del Plata | מגייס | |
| Clinical Trial Site | Mar del Plata | מגייס | |
| Clinical Trial Site | Morón | מגייס | |
| Clinical Trial Site | Quilmes | טרם מגייס | |
| Clinical Trial Site | Ramos Mejía | מגייס | |
| Clinical Trial Site | Rosario | טרם מגייס | |
| Clinical Trial Site | Rosario | מגייס | |
| Clinical Trial Site | Rosario | מגייס | |
| Clinical Trial Site | Rosario | מגייס | |
| Clinical Trial Site | Rosario | מגייס | |
| Clinical Trial Site | Rosario | מגייס | |
| Clinical Trial Site | Rosario | מגייס | |
| Clinical Trial Site | Río Cuarto | מגייס |
1,103 אתרים נוספים מצוינים ברשומת המרשם.
מסמכי המחקר
לא צורפו מסמכים ברשומת מרשם זו.
שינויים לאורך זמן
- 18 בספטמבר 2026
תאריך הסיום הוקדם
Primary completion advanced 7 days
2030-09-302030-09-23
- 18 בספטמבר 2026
אתר נוסף
48 sites added (1153 total)
11051153
- 19 באוגוסט 2026
אתר נוסף
110 sites added (1105 total)
9951105