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A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

30. September 2015 aktualisiert von: AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

915

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, 1431
        • Local Institution
      • Cordoba, Argentinien, 5000
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentinien, 1034
        • Local Institution
      • Capital Federal, Buenos Aires, Argentinien, 1429
        • Local Institution
      • Capital Federal, Buenos Aires, Argentinien, C1056ABJ
        • Local Institution
      • Capital Federal, Buenos Aires, Argentinien, C1425AGC
        • Local Institution
      • Ciudad Auton, Buenos Aires, Argentinien, C1408INH
        • Local Institution
      • Ciudad Auton., Buenos Aires, Argentinien, C1505CWB
        • Local Institution
      • Mar Del Plata, Buenos Aires, Argentinien, 7600
        • Local Institution
      • Zarate, Buenos Aires, Argentinien, 2800
        • Local Institution
    • Cordoba
      • Villa Carlos Paz, Cordoba, Argentinien, 5152
        • Local Institution
  • Brasilien
      • Rio De Janeiro, Brasilien, 20211
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brasilien, 60021
        • Local Institution
    • Minas Gerais
      • Itajuba, Minas Gerais, Brasilien, 37502
        • Local Institution
    • Para
      • Belem, Para, Brasilien, 66073
        • Local Institution
    • Rio Grande Do Sul
      • Caxias Do Sul, Rio Grande Do Sul, Brasilien, 95070
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90020090
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90035
        • Local Institution
    • Sao Paulo
      • Marilia, Sao Paulo, Brasilien, 17519
        • Local Institution
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2R 0X7
        • Local Institution
    • British Columbia
      • Kelowna, British Columbia, Kanada, V1Y 2H4
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3E 3P4
        • Local Institution
    • New Brunswick
      • Bathurst, New Brunswick, Kanada, E2A 4X7
        • Local Institution
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Kanada, A1N 1W7
        • Local Institution
      • St-John, Newfoundland and Labrador, Kanada, A1E 2E2
        • Local Institution
    • Ontario
      • Sarnia, Ontario, Kanada, N7T 4X3
        • Local Institution
      • Thornhill, Ontario, Kanada, L4J 8L7
        • Local Institution
      • Toronto, Ontario, Kanada, M4R 2G4
        • Local Institution
      • Toronto, Ontario, Kanada, M9W 4L6
        • Local Institution
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Kanada, C1A 5Y9
        • Local Institution
    • Quebec
      • Drummondville, Quebec, Kanada, J2B 7T1
        • Local Institution
      • Granby, Quebec, Kanada, J2G 8Z9
        • Local Institution
      • L'Ancienne Lorette, Quebec, Kanada, G2E 2X1
        • Local Institution
      • Mirabel, Quebec, Kanada, J7J 2K8
        • Local Institution
      • St-Leonard, Quebec, Kanada, H1S 3A9
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7K 3H3
        • Local Institution
      • Saskatoon, Saskatchewan, Kanada, S7K 7H9
        • Local Institution
  • Mexiko
      • Durango, Mexiko, 64710
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Mexiko, 11800
        • Local Institution
      • Guadalajara, Distrito Federal, Mexiko, 44670
        • Local Institution
      • Zapopan, Distrito Federal, Mexiko, 45150
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexiko, 44650
        • Local Institution
      • Guadalajara, Jalisco, Mexiko, 44670
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexiko, 64710
        • Local Institution
      • Monterrey, Nuevo Leon, Mexiko, 64460
        • Local Institution
      • Monterrrey, Nuevo Leon, Mexiko, 64700
        • Local Institution
    • Tamaulipas
      • Tampico, Tamaulipas, Mexiko, 89109
        • Local Institution
  • Vereinigte Staaten
    • Arizona
      • Tempe, Arizona, Vereinigte Staaten, 85282
        • Clinical Research Advantage / Desert Clinical Res, Llc
    • California
      • Encino, California, Vereinigte Staaten, 91436
        • Medical Group of Encino
      • Fresno, California, Vereinigte Staaten, 93720
        • Valley Research
      • Los Angeles, California, Vereinigte Staaten, 90023
        • Randall Shue, D.O.
      • Northridge, California, Vereinigte Staaten, 91325
        • Diabetes Medical Center of California
      • San Diego, California, Vereinigte Staaten, 92117
        • Ritchken & First M.D.'S
      • Spring Valley, California, Vereinigte Staaten, 91978
        • Encompass Clinical Research
      • Torrance, California, Vereinigte Staaten, 90505
        • Raikhel, Marina
    • Colorado
      • Colorado Springs, Colorado, Vereinigte Staaten, 80909
        • Express Care Clinical Res
      • Denver, Colorado, Vereinigte Staaten, 80209
        • Denver Internal Medicine
      • Golden, Colorado, Vereinigte Staaten, 80401
        • New West Physicians
    • Florida
      • Altamonte Springs, Florida, Vereinigte Staaten, 32701
        • Central Florida Clinical Trials, Inc.
      • Chipley, Florida, Vereinigte Staaten, 32428
        • Family Care Associates Of Nw Florida
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 56440
        • Health Partners Research Foundation
    • Missouri
      • Chesterfield, Missouri, Vereinigte Staaten, 63017
        • Woodlake Research
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89101
        • Nevada Alliance Against Diabetes
    • North Carolina
      • Morehead City, North Carolina, Vereinigte Staaten, 28557
        • Diabetes & Endocrinology Consultants, PC
    • Ohio
      • Newark, Ohio, Vereinigte Staaten, 43055
        • Newark Physician Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73159
        • Integris Family Care S. Penn
    • Pennsylvania
      • Carlisle, Pennsylvania, Vereinigte Staaten, 17013
        • Cumberland Valley Endocrinology Center, Llc
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15216
        • Banksville Medical Pc
    • South Carolina
      • Summerville, South Carolina, Vereinigte Staaten, 29485
        • Palmetto Clinical Research
      • Taylors, South Carolina, Vereinigte Staaten, 29687
        • Southeastern Research Assoc
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77081
        • Texas Center For Drug Development, P.A.
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • Diabetes & Glandular Disease Research Associates, Inc.
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • S.A.M. Clinical Research Center
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84102
        • Optimum Clinical Research
    • Washington
      • Spokane, Washington, Vereinigte Staaten, 99216
        • Office Of Dr. Gray

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 77 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Key Inclusion Criteria

  • Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
  • Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
  • C-peptide ≥1.0 ng/mL
  • Body mass index ≤45.0 kg/m^2
  • Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key Exclusion Criteria

  • Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
  • Serum total bilirubin level >2 mg/dL
  • Creatinine kinase level >3 times upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
  • Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

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
Placebo-Komparator: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Arzneimittel: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Arzneimittel: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Experimental: Dapagliflozin, 2.5 mg + Metformin
Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Arzneimittel: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Arzneimittel: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Andere Namen:
  • BMS-512148
Experimental: Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Arzneimittel: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Arzneimittel: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Andere Namen:
  • BMS-512148
Experimental: Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Arzneimittel: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Arzneimittel: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Arzneimittel: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Andere Namen:
  • BMS-512148

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Angepasste mittlere Änderung des Hämoglobins A1C (HbA1c) gegenüber dem Ausgangswert in Woche 24 (Last Observation Carried Forward [LOCF])
Zeitfenster: Vom Ausgangswert bis Woche 24
HbA1c wurde von einem Zentrallabor als Prozentsatz des Hämoglobins gemessen. Daten nach Notfallmedikation wurden von dieser Analyse ausgeschlossen. Der Ausgangswert wurde als die letzte Beurteilung vor dem Startdatum und der Startzeit der ersten Dosis der doppelblinden Studienmedikation definiert. In Fällen, in denen der Zeitpunkt der ersten Dosis oder der Beurteilung nicht verfügbar war, wurde der Ausgangswert als die letzte Beurteilung am oder vor dem Datum der ersten Dosis der doppelblinden Studienmedikation definiert. HbA1c-Messungen wurden während der Qualifikations- und Einführungsphase sowie am ersten Tag und in den Wochen 4, 8, 12, 16, 20 und 24 in der Doppelblindphase durchgeführt.
Vom Ausgangswert bis Woche 24

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Zeitfenster: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
Zeitfenster: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Zeitfenster: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
Zeitfenster: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
Zeitfenster: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
Zeitfenster: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
Zeitfenster: From Baseline to Week 1
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 1
Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])
Zeitfenster: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation
Zeitfenster: From Baseline to end of Long-term Period (Week 102)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.
From Baseline to end of Long-term Period (Week 102)
Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality
Zeitfenster: Day 1 to Week 102
BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.
Day 1 to Week 102
Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])
Zeitfenster: Baseline to Week 102
12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.
Baseline to Week 102
Mean Changes From Baseline in Seated Systolic Blood Pressure
Zeitfenster: From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 102
Mean Changes From Baseline in Seated Diastolic Blood Pressure
Zeitfenster: From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 102
Number of Participants With Orthostatic Hypotension
Zeitfenster: From Baseline to Week 102
Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.
From Baseline to Week 102

Mitarbeiter und Ermittler

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

Sponsor

AstraZeneca

Mitarbeiter

Bristol-Myers Squibb

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. September 2007

Primärer Abschluss (Tatsächlich)

1. November 2008

Studienabschluss (Tatsächlich)

1. Mai 2010

Studienanmeldedaten

Zuerst eingereicht

11. September 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. September 2007

Zuerst gepostet (Schätzen)

12. September 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

20. Oktober 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. September 2015

Zuletzt verifiziert

1. September 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MB102-014 LT
  • MB102-014 (Andere Kennung: Other Study ID Numbers:)

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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Drogeninterventionen

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Standorte

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