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
باختصار
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…
المرحلة 3مطلوب 11,000 مشارك1,153 موقعاً35 دولة
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT07181109فتح هذا السجل في ClinicalTrials.govتمت المزامنة أول أمس
يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.
تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.
هل أنت مهتم بهذه الدراسة؟
تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.
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.
ملخص
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.
الحالات
- High Risk Cardiovascular Disease
- Hypertension
- High Cardiovascular Risk
الأهلية
| الجنس | الجميع |
|---|---|
| الأعمار | 18 Years – لا حد أقصى |
| المتطوعون الأصحّاء | لا |
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | تدخّلية |
|---|---|
| المرحلة | المرحلة 3 |
| التخصيص | معشّاة |
| نموذج التدخّل | PARALLEL |
| الغرض الأساسي | TREATMENT |
| التعمية | QUADRUPLE (4) |
| التجنيد | مطلوب 11,000 مشارك |
الجهة الراعية والمتعاونون
- Alnylam Pharmaceuticals الجهة الراعية
- Hoffmann-La Roche المتعاونون
الأذرع والتدخلات
- 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.
التدخلات
- دواء Placebo
Placebo will be administered SC
- دواء Zilebesiran
Zilebesiran will be administered SC
مقاييس النتائج
مقياس النتيجة الأولي
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)
الإطار الزمني Up to approximately 5 years
مقياس النتيجة الثانوي
Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6
الإطار الزمني Baseline and Month 6
مقياس النتيجة الثانوي
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke
الإطار الزمني Up to approximately 5 years
مقياس النتيجة الثانوي
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)
الإطار الزمني Up to approximately 5 years
مقياس النتيجة الثانوي
Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization
الإطار الزمني Up to approximately 5 years
مقياس النتيجة الثانوي
Time to All-cause Death
الإطار الزمني Up to approximately 5 years
التواريخ
| تاريخ البدء | 22 سبتمبر 2025 (فعلي) |
|---|---|
| الإتمام الأولي | 23 سبتمبر 2030 (تقديري) |
| الإتمام | 23 سبتمبر 2030 (تقديري) |
| أول نشر | 18 سبتمبر 2025 (فعلي) |
| آخر تحديث | 18 سبتمبر 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | سبتمبر 2026 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
922 موقعاً قيد التجنيد
Argentina
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Clinical Trial Site | Bahía Blanca | قيد التجنيد | |
| Clinical Trial Site | Bahía Blanca | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | لم يبدأ التجنيد بعد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Buenos Aires | قيد التجنيد | |
| Clinical Trial Site | Ciudadela | قيد التجنيد | |
| Clinical Trial Site | Coronel Suárez | قيد التجنيد | |
| Clinical Trial Site | Corrientes | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Córdoba | قيد التجنيد | |
| Clinical Trial Site | Esperanza | قيد التجنيد | |
| Clinical Trial Site | Formosa | قيد التجنيد | |
| Clinical Trial Site | General San Martín | قيد التجنيد | |
| Clinical Trial Site | Granadero Baigorria | قيد التجنيد | |
| Clinical Trial Site | Lanús Este | قيد التجنيد | |
| Clinical Trial Site | Mar del Plata | قيد التجنيد | |
| Clinical Trial Site | Mar del Plata | قيد التجنيد | |
| Clinical Trial Site | Morón | قيد التجنيد | |
| Clinical Trial Site | Quilmes | لم يبدأ التجنيد بعد | |
| Clinical Trial Site | Ramos Mejía | قيد التجنيد | |
| Clinical Trial Site | Rosario | لم يبدأ التجنيد بعد | |
| Clinical Trial Site | Rosario | قيد التجنيد | |
| Clinical Trial Site | Rosario | قيد التجنيد | |
| Clinical Trial Site | Rosario | قيد التجنيد | |
| Clinical Trial Site | Rosario | قيد التجنيد | |
| Clinical Trial Site | Rosario | قيد التجنيد | |
| Clinical Trial Site | Rosario | قيد التجنيد | |
| Clinical Trial Site | Río Cuarto | قيد التجنيد |
تُدرَج 1,103 مواقع إضافية في سجل السجل.
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
- 18 سبتمبر 2026
قُدِّم تاريخ الإتمام
Primary completion advanced 7 days
2030-09-302030-09-23
- 18 سبتمبر 2026
أُضيف موقع
48 sites added (1153 total)
11051153
- 19 أغسطس 2026
أُضيف موقع
110 sites added (1105 total)
9951105