- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00871871
Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)
22. Juli 2015 aktualisiert von: Merck Sharp & Dohme LLC
A Randomized, Double-Blind, Placebo-Controlled, 2-Part Study to Evaluate the Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis in Obese Patients With Hypertension
This study will measure and compare changes in insulin production and sensitivity using the hyperglycemic clamp technique in obese patients with impaired glucose tolerance and hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide (HCTZ).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
64
Phase
- Phase 1
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
35 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Female participants must be post-menopausal
- Body Mass Index (BMI) of at least 29 kg/m^2
- Weight has been stable over the past 3 months
- Has never been treated for hypertension or is diagnosed with hypertension taking up to 2 anti-hypertensive medications
- Willing to stop hypertension treatment for 14 days prior to randomization and throughout the study
- Does not have a history of diabetes
- In good health with the exception of hypertension
- No history of abnormal heart rhythms
- Part I only: willing to comply with high potassium/low sodium diet for the duration of the study
- Willing to avoid strenuous physical activity during the study
- Nonsmoker and/or has not used nicotine for at least 3 months and agrees to refrain from use of tobacco-containing products throughout the study
- Agrees to refrain from consuming alcohol and caffeine during in-patient periods and to limit consumption at all other times during the study
- Agrees not to consume grapefruit, grapefruit products, and citrus, apple, and pineapple juices 2 weeks prior to administration of the first dose of study drug
Exclusion Criteria:
- History of any illness that may make their participation in the study unsafe or confuse the study results
- Taking spironolactone or eplerenone
- Cannot refrain from using any prescription or non-prescription drugs during the study
- On a weight loss program and is not in the maintenance phase
- Started a weight loss drug within 8 weeks of the first study visit
- Consumes excessive amounts of alcohol or caffeine
- Has had major surgery, donated or lost 1 unit of blood within 4 weeks of the first study visit
- History of multiple and/or severe allergies to drugs or food
- Is dehydrated
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Part I, Placebo-HCTZ
Placebo in Period 1 followed by HCTZ in Period 2
|
HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
Andere Namen:
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
|
Experimental: Part I, HCTZ-Placebo
HCTZ in Period 1, followed by placebo in Period 2
|
HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
Andere Namen:
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
|
Experimental: Part II, Placebo-ISMN
Placebo in Period 1, followed by ISMN in Period 2
|
ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
|
Experimental: Part II, ISMN-Placebo
ISMN in Period 1, followed by placebo in Period 2
|
ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)
Zeitfenster: 90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.
|
90 -120 minutes post-dose
|
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG)
Zeitfenster: 90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.
|
90 -120 minutes post-dose
|
Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT)
Zeitfenster: 90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
NGT participants (FPG <100 mg/dL & 2 hour plasma glucose (PG) <140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG).
IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.
IFG was defined as FPG between 100 and 125 mg/dL at screening.
|
90 -120 minutes post-dose
|
Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state
Zeitfenster: 90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration.
The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.
|
90 -120 minutes post-dose
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)
Zeitfenster: 90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration.
The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.
IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.
|
90 -120 minutes post-dose
|
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG)
Zeitfenster: 90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration.
The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.
IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.
|
90 -120 minutes post-dose
|
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT)
Zeitfenster: 90 -120 minutes post-dose
|
Steady state was defined as 90-120 minutes post-dose.
The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC).
Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes.
NGT participants (FPG <100 mg/dL & 2 hour PG <140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening.
IGT - defined as a 2 hour PG >= 140 and <= 199 mg/dL during a 75g OGTT at screening.
IFG - defined as FPG between 100 and 125 mg/dL at screening.
|
90 -120 minutes post-dose
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2009
Primärer Abschluss (Tatsächlich)
1. Februar 2010
Studienabschluss (Tatsächlich)
1. März 2010
Studienanmeldedaten
Zuerst eingereicht
27. März 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. März 2009
Zuerst gepostet (Schätzen)
30. März 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
28. Juli 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. Juli 2015
Zuletzt verifiziert
1. Juli 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Hypertonie
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antihypertensive Mittel
- Vasodilatator-Wirkstoffe
- Natriuretische Mittel
- Membrantransportmodulatoren
- Diuretika, Osmotika
- Diuretika
- Natriumchlorid-Symporter-Inhibitoren
- Stickoxid-Donatoren
- Hydrochlorothiazid
- Isosorbid
- Isosorbiddinitrat
- Isosorbid-5-mononitrat
Andere Studien-ID-Nummern
- 0000-117
- 2009_567
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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