- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00150631
Danish Hypertension Prevention Project - DHYPP
Danish Hypertension Prevention Project
Przegląd badań
Szczegółowy opis
Essential hypertension, a major health problem worldwide, is a disease generally considered to require life-long treatment. However, evidence suggests that hypertension is caused by specific phenotypic changes caused by a combination of genetic and environmental factors. Thus, in principle, hypertension could be prevented by prevention of these phenotypic changes. Animal data indicate that early treatment that blocks the renin-angiotensin system have long-term effects after treatment withdrawal. The present human study is testing whether early treatment (with the AT1- antagonist) is able to have a persistent effect after stopping treatment.
This is a monocenter, double-blind, randomized, placebo-controlled study in healthy, normotensive (consultation diastolic blood pressure over 2 visits < 85 mmHg) subjects 18 to 36 years of age whose both parents have essential hypertension. The primary objective is to determine whether pharmacological treatment with an angiotensin receptor blocker is able to restrain or delay the progression to hypertension. Secondary objectives are to investigate whether any long-term effect on blood pressure is related to the effect of treatment on renal haemodynamic function, or on the left ventricle mass.
Subjects are recruited by use of hospital registers to identify persons who have received the indication essential hypertension, and are of an age that they may have children of the appropriate age. These persons are then mailed asking if they do have children with a partner who is also hypertensive, and asking permission to contact the children. The diagnosis of hypertension of the parents is checked following evaluation by the physicians who are treating them.
One hundred subjects were randomly assigned to one of two treatment groups: placebo; or candesartan cilexetil, 16 mg, once daily. Before inclusion and after 12 months of treatment glomerular filtration rate, renal vascular resistance, echocardiography and 24-hour blood pressure monitoring were performed. Subjects were evaluated at 0.5, 1, 2, 4, 6 and 10 months to ensure compliance and to control blood pressure. After 12-months of treatment, 24-hour blood pressure monitoring were performed in a scheduled manner over a 10-year period. The primary effect parameter is 24-hour blood pressure measured 10 years after withdrawal of treatment. Interim analyses will be made at 1, 2 and 5 years by an independent data committee. Secondary effect parameters will be numbers on antihypertensive treatment at 2, 5 and 10 years after withdrawal, as well as the effect of treatment on renal vascular resistance and left ventricular mass.
A substudy is comparing renal haemodynamics and genetic profil of the subjects with persons having normotensive parents.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Aarhus, Dania, 8000
- Karin Skov
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Both parents have essential hypertension
- Age 18 - 36 years
- Caucasians
- Diastolic blood pressure less than 85 mmHg at inclusion time
- Female participants using orale anticonceptives ot intrauterine devices
Exclusion Criteria:
- Clinical or biochemically signs of disease in kidney, liver, or endocrine organs
- Diastolic blood pressure above 85 mmHg at inclusion time
- Pregnancy or pregnancy wish
- Daily medication, except for orale anticoncetives -
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Komparator placebo: active (candesartan)
12 mo treatment with candesartan
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placebo controlled double blind
Inne nazwy:
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Komparator placebo: placebo
12 mo placebo treatment
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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The primary outcome is to determine whether pharmacological treatment with an angiotensin receptor blocker is able to restrain or delay the progression to hypertension.
Ramy czasowe: 10 years
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10 years
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Secondary outcomes are to investigate whether any long-term effect on blood pressure is related to the effect of treatment on renal haemodynamic function, or on the left ventricle mass.
Ramy czasowe: 1 year
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1 year
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: michael mulvany, prof, Dept. of Pharmacology, Aarhus University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 20000114
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Badania kliniczne na Candesartan
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GlaxoSmithKlineZakończony