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Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)

8. Juni 2015 aktualisiert von: Merck Sharp & Dohme LLC

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK0736 and MK0916 in Hypertensive Patients

The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure).

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

249

Phase

  • Phase 2

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

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Hypertension systolic blood pressure (SBP) </= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg

Exclusion Criteria:

  • Pre-menopausal women
  • patients currently taking more than two (2) blood pressure lowering medications
  • Body Mas Index (BMI)>40 kg/m2 (morbidly obese patients)
  • History of Alcohol abuse (<3 Years)
  • History of diabetes,chronic kidney disease, Active liver disease, recent heart attack or stroke

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: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: High BMI:MK-0736 2mg→Placebo
Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
Arzneimittel: Placebo
Arzneimittel: MK0736
Experimental: High BMI:MK-0736 7mg→Placebo
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
Arzneimittel: Placebo
Arzneimittel: MK0736
Experimental: High BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Arzneimittel: MK0916
Placebo-Komparator: High BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Arzneimittel: Placebo
Experimental: Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Arzneimittel: MK0916
Placebo-Komparator: Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Arzneimittel: Placebo

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Zeitfenster: Baseline and Week 12 (end of Phase A)
Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.
Baseline and Week 12 (end of Phase A)
Number of Participants Who Reported a Clinical Adverse Event
Zeitfenster: 24 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
24 weeks
Number of Participants Who Reported a Laboratory Adverse Event
Zeitfenster: 24 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
24 weeks
Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event
Zeitfenster: 24 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
24 weeks
Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event
Zeitfenster: 24 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
24 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Zeitfenster: Baseline and Week 12 (end of Phase A)
Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.
Baseline and Week 12 (end of Phase A)
Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI
Zeitfenster: Baseline and Week 12 (end of Phase A)
Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.
Baseline and Week 12 (end of Phase A)
Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI
Zeitfenster: Baseline and Week 12 (end of Phase A)
Waist circumference measured in cm at baseline and after 12 weeks of study drug administration
Baseline and Week 12 (end of Phase A)
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Zeitfenster: Baseline and Week 12 (end of Phase A)
LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.
Baseline and Week 12 (end of Phase A)
Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI
Zeitfenster: Baseline and Week 12 (end of Phase A)
HDL-C measured at baseline and after 12 weeks of study drug administration.
Baseline and Week 12 (end of Phase A)
Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Zeitfenster: Baseline and Week 12 (end of Phase A)
TG measured at baseline and after 12 weeks of study drug administration
Baseline and Week 12 (end of Phase A)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Merck Sharp & Dohme LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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. November 2005

Primärer Abschluss (Tatsächlich)

1. Januar 2007

Studienabschluss (Tatsächlich)

1. Januar 2007

Studienanmeldedaten

Zuerst eingereicht

10. Januar 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Januar 2006

Zuerst gepostet (Schätzen)

11. Januar 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

3. Juli 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2015

Zuletzt verifiziert

1. Juni 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 0736-003
  • 2006_004

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