- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02871310
Vasoactive Effects of IQP-AS-118 in Healthy Individuals
10 februari 2020 uppdaterad av: 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.
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Berlin, Tyskland, 10369
- analyze & realize GmbH
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
Placebo-jämförare: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in EndoPAT (chronic effect)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in EndoPAT (acute effect)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 12 weeks
|
Assessed by the subjects and investigator at end of each intervention (inclusive of 4 weeks of wash-out period)
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12 weeks
|
Changes in SF- 12
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Global assessment of tolerability
Tidsram: 12 weeks
|
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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Ralf Uebelhack, analyze & realize GmbH
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 mars 2018
Primärt slutförande (Förväntat)
1 december 2018
Avslutad studie (Förväntat)
1 december 2018
Studieregistreringsdatum
Först inskickad
10 augusti 2016
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2016
Första postat (Uppskatta)
18 augusti 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 februari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 februari 2020
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- INQ/030815
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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