- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02871310
Vasoactive Effects of IQP-AS-118 in Healthy Individuals
10 febbraio 2020 aggiornato da: InQpharm Group
Randomized, Double-Blind, Placebo-Controlled, Monocenter, Crossover Investigation to Evaluate the Vasoactive Effects of IQP-AS-118 in Healthy Individuals: A Pilot Study
The main objective of this study is to evaluate the benefit of IQP-AS-118 on the vasoactive effects in healthy subjects.
Panoramica dello studio
Stato
Ritirato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
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Berlin, Germania, 10369
- analyze & realize GmbH
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 45 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Caucasian males and females 45-65 years of age
- Body mass index (BMI) of 25.0-29.9 kg/m2
Blood pressure (BP) at screening:
- systolic blood pressure (SBP) ≤ 140 mmHg or
- diastolic blood pressure (DBP) ≤ 90 mmHg
- EndoPAT score: ≤ 2.00) at screening
- Generally in good health, in particular an electrocardiogram (ECG) without pathological findings at screening
Readiness to comply with study procedures, in particular:
- Consumption of the investigational product (IP) / placebo according to investigator's advise
- Maintaining the same level of physical activity and usual diet during the entire study
- Accepting blood draws
- Able to undergo an EndoPAT assessment
- Complying with visits and all respective requirements for BP and EndoPAT measurements
- Filling in diaries/questionnaires
- Non-smoker since at least 6 months prior to screening and during the study
- Stable body weight in the last 3 months prior to screening (<3 kg self-reported change) and during the study
- Concomitant medications must have been stable at least during the last 1 month prior to screening, if applicable
- In women: postmenopausal for at least 12 months Participation is based upon written informed consent form (ICF) by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
Exclusion Criteria:
- Known sensitivity to any components of the IP
- Known primary or secondary hypertension or white-coat hypertension
- Known impaired endothelial function as per investigator's judgement
- Clinically significant disturbances in lipid metabolism e.g. known genetic hyperlipidemia
- Known type-1 / type-2-diabetes
- Untreated or non-stabilized thyroid disorder
History and/or presence of clinically significant cardiovascular disease as per investigator's judgement:
- Known congenital heart defects
- Myocardial infarction, heart failure, angina pectoris, life-threatening arrhythmia or stroke within the last 6 months prior to screening
- Existing thrombosis or disposition to thrombosis
Any other known significant or serious condition / disease that renders subjects ineligible, e.g.:
- History of malignancy within ≤5 years prior to screening
- Bleeding disorder and/or need for anticoagulants or anti-platelet agents
- Current psychiatric care and/or use of neuroleptics
- Bariatric surgery in the last 12 months prior to screening
- Any known metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which in the investigator's opinion could interfere with the results of the study or the safety of the subject
- Known arm lymphedema (e.g. due to mastectomy)
- Other clinically relevant excursions of safety parameters or any other clinically significant abnormality in hematology and/or biochemistry at the Investigator's judgement
- Dietary habits and/or restrictions that may affect the study outcome
- Eating disorder or participation in a weight loss program
- Use of medications (e.g. statins, renin angiotensin system inhibitors, nevibolol, carvedilol, calcium channel blockers) or supplements that can influence vascular endothelial function and/or blood flow (e.g. garlic, cocoa) within the last 4 weeks prior to screening and during the study
- Use of antiplatelet agents and / or anticoagulants (e.g. warfarin, acetylsalicylic acid) within the last 4 weeks prior to screening and during the study
- Use of medications or supplements that can influence SBP or DBP (e.g. ACE inhibitors, diuretics, calcium channel, α- or ß-blockers, grape seed extract, coenzyme Q10 etc.) within the last 4 weeks prior to screening and during the study
- Use of lipid lowering medications (affecting lipid metabolism, platelet function or antioxidant status, etc.) and/or dietary supplements (e.g. omega-3 fatty acids, green tea extract, calcium, red yeast rice, phytosterols (incl. enriched products such as e.g. Becel), niacin,, glucomannan or chitosan ) within the last 4 weeks prior to screening and during the study
- Use of medications that can influence cholesterol levels significantly (e.g. corticosteroids, amiodarone, estrogen, anabolic steroids) according to investigator's judgement
- Use of weight loss treatment
- Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- Drug abuse
- Reported participation in night shift work 2 weeks prior to screening and/or during the study
- Participation in another study or blood donation during the last 30 days prior to screening and during the study
- Any other reason deemed suitable for exclusion per investigator's judgment, e.g. insufficient compliance with study procedures
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: IQP-AS-118
To be taken once daily dosing of 1 tablet in the morning with 250 mL of water.
The tablets should not be chewed, but swallowed whole.
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1 tablet in the morning
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Comparatore placebo: Placebo
To be taken once daily dosing of 1 tablet in the morning with 250 mL of water.
The tablets should not be chewed, but swallowed whole.
|
1 tablet in the morning
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in EndoPAT (chronic effect)
Lasso di tempo: 12 weeks
|
Pre-dose at the end vs. start of each intervention (week 4 vs. week 0 and week 12 vs.
week 8, respectively) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in EndoPAT (acute effect)
Lasso di tempo: 12 weeks
|
3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Changes in ex vivo blood platelet aggregation / adhesion (acute effect)
Lasso di tempo: 12 weeks
|
3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Changes in ex vivo blood platelet aggregation / adhesion pre-dose (chronic effect)
Lasso di tempo: 12 weeks
|
End vs. start of each intervention (week 4 vs. week 0 and week 12 vs.
week 8, respectively) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Changes in blood coagulation / clotting parameters (acute effect)
Lasso di tempo: 12 weeks
|
3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Changes in blood coagulation / clotting parameters predose (chronic effect)
Lasso di tempo: 12 weeks
|
End vs. start of each intervention (week 4 vs. week 0 and week 12 vs.
week 8, respectively) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Global evaluation of benefit
Lasso di tempo: 12 weeks
|
Assessed by the subjects and investigator at end of each intervention (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Changes in SF- 12
Lasso di tempo: 12 weeks
|
End vs. start of each intervention (week 4 vs. week 0 and week 12 vs.
week 8, respectively) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Physical examination
Lasso di tempo: 12 weeks
|
End of each intervention vs. screening (Week 4 vs. screening, week 12 vs.
screening) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Pulse rate
Lasso di tempo: 12 weeks
|
End vs. start of each intervention (Week 4 vs. week 0, week 12 vs.
week 8) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Systolic Blood Pressure
Lasso di tempo: 12 weeks
|
End vs. start of each intervention (Week 4 vs. week 0, week 12 vs.
week 8) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Diastolic Blood Pressure
Lasso di tempo: 12 weeks
|
End vs. start of each intervention (Week 4 vs. week 0, week 12 vs.
week 8) (inclusive of 4 weeks of wash-out period)
|
12 weeks
|
Assessment of Adverse Events
Lasso di tempo: 12 weeks
|
Start and end of each intervention (Week 0, week 4, week 8 and week 12) (inclusive of 4 weeks of wash-out period)
|
12 weeks
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Global assessment of tolerability
Lasso di tempo: 12 weeks
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Assessed by the subjects and investigator (4-point categorical scale) at week 4 and week 12
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12 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Ralf Uebelhack, analyze & realize GmbH
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
1 marzo 2018
Completamento primario (Anticipato)
1 dicembre 2018
Completamento dello studio (Anticipato)
1 dicembre 2018
Date di iscrizione allo studio
Primo inviato
10 agosto 2016
Primo inviato che soddisfa i criteri di controllo qualità
14 agosto 2016
Primo Inserito (Stima)
18 agosto 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 febbraio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 febbraio 2020
Ultimo verificato
1 gennaio 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- INQ/030815
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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