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Observational study on the effects of Nebilet for controlling blood pressure in hypertensive patients

IMPACT of Nebilet in Blood Pressure Control in Patients With HYpertension: An Observational, Longitudinal Study

Observational A.Menarini Asia-Pacific Holdings Pte Ltd · NCT06938516

This study is testing how well Nebilet helps people with high blood pressure manage their condition and improve their overall health over three years.

Quick facts

Study typeObservational
Enrollment4537 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorA.Menarini Asia-Pacific Holdings Pte Ltd Industry-sponsored
Locations49 sites (Semarang, Central Java and 48 other locations)
Trial IDNCT06938516 on ClinicalTrials.gov

What this trial studies

The HYIMPACT study is a multinational, multicenter observational study designed to evaluate the effectiveness and safety of Nebilet® (nebivolol) in patients with hypertension. It aims to track changes in blood pressure over a period of up to three years, assessing treatment adherence, quality of life, and cardiovascular outcomes. Approximately 5,000 hypertensive patients across seven Asian countries will be enrolled, focusing on those newly initiated on Nebilet® or those who have been on it for a short duration. The study will provide valuable real-world evidence regarding the long-term impact of Nebilet® on blood pressure control and related health outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed or uncontrolled hypertension, who are either newly prescribed Nebilet® or have been on it for no more than two weeks.

Not a fit: Patients who have experienced a recent cardiovascular event within the last three months or have severe heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective long-term management of hypertension using Nebilet®, potentially improving patient outcomes.

How similar studies have performed: While there is existing evidence on the efficacy of nebivolol, this study aims to provide novel real-world data on its long-term effectiveness in diverse populations, making it a significant addition to the current literature.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adult patients ≥ 18 years of age with either newly diagnosed or uncontrolled hypertension (office SBP ≥140 and/or DBP ≥90 mmHg recorded at the time of screening) as per ESC/ESH guidelines 2018.
* Hypertensive patients - with or without cardiovascular comorbidities (such as coronary artery disease, heart failure, peripheral artery disease, cerebrovascular disease, arrhythmias, and valvular heart disease) - who are newly prescribed or are already on Nebilet based treatment (no more than for 2 weeks at screening).
* Hypertensive patients willing to provide consent to participate in the study.
* Women of reproductive age who are willing to use adequate means of contraception.

Exclusion Criteria:

* Patients with recent cardiovascular event within less than 3 months.
* Patient with heart failure based on New York Heart Association (NYHA) Functional Classification- Class IV.
* Patients with contraindications to Nebilet based treatment as per respective Summary of Product Characteristic (SmPC) which in the treating physician's judgment may jeopardize the subject by his or her participation in this study or may hamper his or her ability to perform and complete procedures required in the study.

Where this trial is running

Semarang, Central Java and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HypertensionHigh Blood PressureNebivolol in high blood pressureUse of Nebilet in high blood pressure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.