- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01771783
RAS-Peptide-Profile Study in Healthy Male Subjects (RAS)
Single-center, Randomized, Open-label, 3-way Crossover Study to Characterize the RAS-peptide-profile After Single and Repeated Oral Administration of Different RAS-inhibitors in Healthy Male Subjects
The primary objective is the characterization of the RAS peptide profiles after single and repeated oral administration of a renin inhibitor, an ACE inhibitor and an angiotensin receptor blocker in healthy volunteers.
Secondary objectives are the correlation of RAS peptide profiles with pharmacokinetic profiles of the different RAS inhibitors and with pharmacodynamic parameters such as blood pressure and heart rate. Output of the classic RAS system will be assessed using aldosterone concentrations. Fluid and sodium intake will be monitored using sodium concentration and total volume in 24h urine.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Basel, Zwitserland, 4031
- Department Clinical Pharmacology, University Hospital Basel
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Male aged between 18 and 45 years (inclusive) at screening.
- Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) and body weight at least 50 kg at screening.
- Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 60-90 mmHg and heart rate (HR) 45-90 bpm (inclusive), measured on the leading arm*, after 5 min in the supine position at screening.
- Signed informed consent prior to any study-mandated procedure.
- No clinically significant findings on the physical examination at screening.
- 12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening.
- Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.
Ability to communicate well with the investigator and to understand and comply with the requirements of the study.
- leading arm right = writing with right hand
Exclusion Criteria:
- Smoking > 5 cigarettes per day
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- Loss of ≥ 250 ml of blood within 3 months prior to screening.
- Treatment with an investigational drug within 30 days prior to screening.
- Previous treatment with any prescribed or over the counter medications (including herbal medicines such as St John's Wort) within 2 weeks prior to the intended start of study.
- Legal incapacity or limited legal capacity at screening.
- Positive results from urine drug screen at screening.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.
- Known hypersensitivity to any excipients of the drug formulations.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: ACEI-ARB-RI
angiotensin converting enzyme inhibitor (ACEI) angiotensin receptor antagonist (ARB) renin inhibitor (RI)
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Andere namen:
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Experimenteel: ARB-RI-ACEI
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Andere namen:
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Experimenteel: RI-ACEI-ARB
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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RAS-peptide profile
Tijdsspanne: 0-192h
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0-192h
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Blood pressure and heart rate
Tijdsspanne: 0-192 h
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0-192 h
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Aldosterone concentrations
Tijdsspanne: 0-192 h
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0-192 h
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Manuel Haschke, PD Dr. med., Clinical Pharmacology, University Hospital Basel
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- USBMH-001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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