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NCT06938516Recruiting

Prospective Observational Study On The Impact Of Nebilet In Blood Pressure Control In Hypertensive Patients (HYIMPACT)

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

Source: ClinicalTrials.gov · Last updated 22 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The HYIMPACT study (IMPACT of Nebilet® in Blood Pressure Control in Patients with Hypertension) is a multinational, multicenter, observational, prospective, longitudinal real-world evidence study designed to assess the effectiveness and safety of Nebilet® (nebivolol) in hypertensive patients. The study aims to evaluate changes in systolic and diastolic blood pressure from baseline to 12, 24, and 36 months, as well as treatment adherence, quality of life, prescription patterns, and cardiovascular outcomes. A total of approximately 5,000 hypertensive patients with or without cardiovascular comorbidities will be enrolled across seven Asian countries (Malaysia, Indonesia, the Philippines, Korea, Vietnam, Thailand, and Taiwan). Patients newly initiated on Nebilet®-based treatment or already receiving Nebilet® for no more than two weeks prior to screening will be eligible for inclusion. Patients will be followed at regular intervals for up to three years. The study will also assess the correlation between home and office blood pressure measurements and compare Nebilet® monotherapy with combination therapy in achieving target blood pressure control. The findings from this study will provide real-world insights into the clinical management of hypertension with Nebilet® and its impact on patient outcomes.

Status (registry)
Recruiting
Study type
Observational
Enrollment
4537 (estimated)
First submitted
4 Apr 2025
Start date
20 Dec 2023
Primary completion date
30 Nov 2028
Lead sponsor
A.Menarini Asia-Pacific Holdings Pte Ltd
NCT number
NCT06938516

What you commit to

  • Study type: Observational
  • Planned participants: 4537
  • From 20 Dec 2023 to the primary completion date, 30 Nov 2028
  • 49 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient with heart failure based on New York Heart Association (NYHA) Functional Classification- Class IV.

Other

  • Patients with recent cardiovascular event within less than 3 months.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (49)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Borromeus Hospital
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BandungIndonesiaRecruiting
Advent Hospital
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BandungIndonesiaRecruiting
National Cardiovascular Center Harapan Kita Hospital
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JakartaIndonesiaRecruiting
Metropolitan Medical Centre Hospital
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JakartaIndonesiaRecruiting
Stella Maris Hospital
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MakassarIndonesiaRecruiting
Semen Padang Hospital
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PadangIndonesiaRecruiting
Bukit Asam Medika Hospital
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PalembangIndonesiaRecruiting
PT Ekamas International Hospital
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PekanbaruIndonesiaRecruiting
Bidakara Medical Centre
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SelatanIndonesiaRecruiting
Telogorejo Hospital
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SemarangIndonesiaRecruiting
RSUD Syamsudin Hospital
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SukabumiIndonesiaRecruiting
Husada Utama Hospital
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SurabayaIndonesiaRecruiting
Premere Surabaya Hospital
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SurabayaIndonesiaRecruiting
Bethesda Hospital
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YogyakartaIndonesiaRecruiting
Panti rapih Hospital
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YogyakartaIndonesiaRecruiting
Chonnam National University Hospital
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GwangjuSouth KoreaRecruiting
Eunpyeong St. Mary's Hospital
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SeoulSouth KoreaRecruiting
Kangbuk Samsung Hospital
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SeoulSouth KoreaRecruiting
Bukit Tinggi Medical Centre
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KlangMalaysiaRecruiting
Klinik Pembangunan Sdn. Bhd
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Kuala LumpurMalaysiaRecruiting
DrThong,Leow,Chiam & Partners
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Kuala LumpurMalaysiaRecruiting
Pantai HKL
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Kuala LumpurMalaysiaRecruiting
Columbia Asia Hospital Seremban
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SerembanMalaysiaRecruiting
Mawar Medical Centre
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SerembanMalaysiaActive, not recruiting
Mary Mediatrix Medical Center
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LipaPhilippinesRecruiting
Veterans Memorial Medical Center
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Quezon CityPhilippinesRecruiting
Chiang Mai University
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Chiang MaiThailandRecruiting
Burapha University
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Chon BuriThailandRecruiting
Vajira Hospital Namindradhiraj University
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DusitThailandRecruiting
Anand Mahidhol Hospital
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LopburiThailandRecruiting
Wetchakarunrasm Hospital
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Nong ChokThailandRecruiting
Central Chet Institute
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NonthaburiThailandRecruiting
Changhua Christian Hospital (CCH)
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ChanghuaTaiwanRecruiting
Hualien Tzu-Chi Hospital (HTCH)
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Hualien CityTaiwanRecruiting
Kaohsiung Medical University Hospital (KMUH)
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Kaohsiung CityTaiwanRecruiting
Far Eastern Memorial Hospital (FEMH)
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New Taipei CityTaiwanRecruiting
Chang Gung Memorial Hospital-Chiayi branch (CGMH-CY)
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PoziTaiwanNot yet recruiting
Taichung Veterans General Hospital (TVGH)
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TaichungTaiwanRecruiting
Chi-Mei Medical Center (CMC)
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TainanTaiwanActive, not recruiting
National Cheng Kung University Hospital Nckuh
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TainanTaiwanRecruiting
Taipei Medical University Hospital (TMUH)
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TaipeiTaiwanRecruiting
Asia University Hospital (AUH)
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TaipeiTaiwanRecruiting
National Taiwan University Hospital NTUH
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TaipeiTaiwanRecruiting
MacKay Memorial Hospital (MMH)
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TaipeiTaiwanRecruiting
Chung Gung Memorial Hospital-Linkou Branch (CGMH-LK)
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TaoyuanTaiwanActive, not recruiting
CanTho General Hospital
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Can ThoVietnamRecruiting
Hanoi Heart Hospital
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HanoiVietnamRecruiting
Cho Ray Hospital
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Ho Chi Minh CityVietnamCompleted
Hue Central Hospital
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HuếVietnamRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.