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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

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

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.

Methodological rigourDEFINITIVE

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

ScaleMEGA

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

Investigator standingUNKNOWN

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

الأهلية
الجنسالجميع
الأعمار18 Yearsلا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Inclusion Criteria: * Is 18 years or older for patients with established cardiovascular disease (CVD) * Is 55 years or older for patients with high risk for CVD * Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD * Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic Exclusion Criteria: * Has known history of secondary hypertension * Has symptomatic orthostatic hypotension * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN) * Has total serum bilirubin \>1.5×ULN * Has international normalized ratio (INR) \>1.5 * Has serum potassium \>4.8 mEq/L * Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 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

  1. 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

  2. مقياس النتيجة الثانوي

    Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6

    الإطار الزمني Baseline and Month 6

  3. 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

  4. 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

  5. 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

  6. مقياس النتيجة الثانوي

    Time to All-cause Death

    الإطار الزمني Up to approximately 5 years

التواريخ

التواريخ
تاريخ البدء22 سبتمبر 2025 (فعلي)
الإتمام الأولي23 سبتمبر 2030 (تقديري)
الإتمام23 سبتمبر 2030 (تقديري)
أول نشر18 سبتمبر 2025 (فعلي)
آخر تحديث18 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

922 موقعاً قيد التجنيد

Argentina

Argentina
المنشأةالمدينةالولاية أو المنطقةالحالة
Clinical Trial SiteBahía Blancaقيد التجنيد
Clinical Trial SiteBahía Blancaقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesقيد التجنيد
Clinical Trial SiteBuenos Airesلم يبدأ التجنيد بعد
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Clinical Trial SiteBuenos Airesقيد التجنيد
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Clinical Trial SiteLanús Esteقيد التجنيد
Clinical Trial SiteMar del Plataقيد التجنيد
Clinical Trial SiteMar del Plataقيد التجنيد
Clinical Trial SiteMorónقيد التجنيد
Clinical Trial SiteQuilmesلم يبدأ التجنيد بعد
Clinical Trial SiteRamos Mejíaقيد التجنيد
Clinical Trial SiteRosarioلم يبدأ التجنيد بعد
Clinical Trial SiteRosarioقيد التجنيد
Clinical Trial SiteRosarioقيد التجنيد
Clinical Trial SiteRosarioقيد التجنيد
Clinical Trial SiteRosarioقيد التجنيد
Clinical Trial SiteRosarioقيد التجنيد
Clinical Trial SiteRosarioقيد التجنيد
Clinical Trial SiteRío Cuartoقيد التجنيد

تُدرَج 1,103 مواقع إضافية في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 18 سبتمبر 2026

    قُدِّم تاريخ الإتمام

    Primary completion advanced 7 days

    2030-09-302030-09-23

  2. 18 سبتمبر 2026

    أُضيف موقع

    48 sites added (1153 total)

    11051153

  3. 19 أغسطس 2026

    أُضيف موقع

    110 sites added (1105 total)

    9951105