- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01152190
A Study in Benign Prostatic Hyperplasia
27 mars 2013 uppdaterad av: Eli Lilly and Company
A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
97
Fas
- Fas 3
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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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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Garden City, New York, Förenta staterna, 11530
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York, New York, Förenta staterna, 10016
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bergamo, Italien, 24128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Innsbruck, Österrike, 6020
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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 och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria
- Present with benign prostatic hyperplasia
- Provide signed informed consent at the screening
- Agree not to use other treatment for Benign Prostatic Hyperplasia, Erectile Dysfunction or Overactive Bladder (including herbal treatments) during the study
Exclusion Criteria
- Have prostatic cancer or are being treated for cancer.
- Any condition that may negatively influence the transrectal ultrasound.
- Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
- Any evidence of moderate to severe cardiac disease
- Have had any of the following in the past 90 days: chest pain (called unstable angina or angina) that requires treatment, heart attack also known as myocardial infarction, heart bypass surgery (called coronary artery bypass graft surgery), had a procedure to open up blood vessels in the heart know as angioplasty or stent placement (percutaneous coronary intervention), positive cardiac stress test without effective cardiac intervention.
- Have very high or very low blood pressure.
- Have uncontrolled diabetes.
- Have certain problems with your kidneys, liver, or nervous system.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Placebo
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Administered orally, once daily for 8 weeks
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Experimentell: 5 milligrams (mg) Tadalafil
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Administered orally, once daily for 8 weeks
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone
Tidsram: Baseline, Week 8
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Arterial RI was a measure of vascular resistance using Doppler ultrasound.
RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased.
The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.
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Baseline, Week 8
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone
Tidsram: Baseline, Week 4
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Arterial RI was a measure of vascular resistance using Doppler ultrasound.
RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased.
The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.
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Baseline, Week 4
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Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck
Tidsram: Baseline, Week 4 and Week 8
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Arterial RI was a measure of vascular resistance using Doppler ultrasound.
RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased.
The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.
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Baseline, Week 4 and Week 8
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Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck
Tidsram: Baseline, Week 4 and Week 8
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CPI quantified blood flow in a pre-specified region of interest by using color Doppler imaging.
CPI was the mean color pixel intensity in the region of interest and scores could range from 0 to 160.
An increase in CPI reflected an increase in blood flow.
The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.
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Baseline, Week 4 and Week 8
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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
1 september 2010
Primärt slutförande (Faktisk)
1 juli 2012
Avslutad studie (Faktisk)
1 juli 2012
Studieregistreringsdatum
Först inskickad
25 juni 2010
Först inskickad som uppfyllde QC-kriterierna
25 juni 2010
Första postat (Uppskatta)
29 juni 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 maj 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 mars 2013
Senast verifierad
1 mars 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 13469
- H6D-MC-LVIR (Annan identifierare: Eli Lilly and Company)
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 .
Kliniska prövningar på Benign prostatahyperplasi
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St. Joseph's Healthcare HamiltonOntario Ministry of Health and Long Term CareAvslutadBenign prostatahyperplasiKanada
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Catholic University of the Sacred HeartAvslutadBenign prostatahyperplasi (BPH) | Benign prostataförstoring (BPE)Italien
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San Carlo di Nancy HospitalElesta S.R.L.AvslutadBenign prostatahyperplasi | Benign prostatahypertrofi | Benign prostatahypertrofi med utflödeshinder | ProstatahyperplasiItalien
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IMBiotechnologies Ltd.AvslutadBenign prostatahyperplasi | Benign prostatahypertrofiKanada
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IRCCS Policlinico S. MatteoAvslutadBenign prostatahyperplasi | Benign prostatahypertrofi med utflödeshinderItalien
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Yonsei UniversityAvslutadBPH (benign prostatahyperplasi) | TURP (Transuretral resektion av prostata)Korea, Republiken av
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Academisch Medisch Centrum - Universiteit van Amsterdam...Har inte rekryterat ännuSymtom i de nedre urinvägarna | Benign prostatahyperplasi | Benign prostatahypertrofi med utflödeshinder
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Assiut UniversityHar inte rekryterat ännu
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NeoTract, Inc.Har inte rekryterat ännu
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Assiut UniversityHar inte rekryterat ännu
Kliniska prövningar på Tadalafil
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Institute for the Study of Urological Diseases,...RekryteringErektil dysfunktionGrekland
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Centro Universitario de Ciencias de la Salud, MexicoOkändFetma och erektil dysfunktionMexiko
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Saint Petersburg State University, RussiaRekryteringErektil dysfunktionRyska Federationen
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Futura Medical Developments Ltd.AvslutadKlinisk undersökning med MED3000 Gel eller Tadalafil tabletter vid behandling av erektil dysfunktionErektil dysfunktionFörenta staterna, Bulgarien, Georgien, Polen
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University of PernambucoOkänd
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ActelionAktiv, inte rekryterandePulmonell arteriell hypertension (PAH) (WHO Group 1 PH)Förenta staterna, Japan, Taiwan, Kalkon, Kanada, Kina, Tyskland, Spanien, Italien, Malaysia, Ungern, Ryska Federationen, Brasilien, Australien, Bulgarien, Tjeckien, Mexiko, Polen, Sydafrika
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Cairo UniversityOkändErektil dysfunktionEgypten
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Cedars-Sinai Medical CenterAvslutad
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Regina Elena Cancer InstituteRekrytering
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Mark FeinglosEli Lilly and Company; Duke UniversityIndragenIllamående | Kräkningar | Gastropares | Diabetisk gastroparesFörenta staterna