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Клинические исследования в Украине

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Исследования / № 00056407

Описание
Краткое название"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
Полное названиеA Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
СпонсорGlaxoSmithKline
Industry
ИсточникGlaxoSmithKline
Под контролемCanada: Health Canada
Sweden: Medical Products Agency
United States: Food and Drug Administration
Краткое описаниеThis 4-year study will compare how safe and effective an oral investigational medicine is
(compared to placebo) in preventing the development of prostate cancer in men that are
defined by the study entrance criteria as being at an increased risk for prostate cancer.
Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits),
and a prostate biopsy will be performed at 2 and 4 years of treatment.
СостояниеЗавершено
Дата началаMarch 2003
ФазаPhase 3
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Набор0
КритерииInclusion criteria:

- Informed consent to participate in study.

- Have had a single negative prostate biopsy within 6 months prior to enrollment in
study.

- Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or
a PSA between 3.0 and 10 if over age 60.

- Ability and will to participate in study for 4 years.

Exclusion criteria:

- More than one previous negative prostate biopsy.

- History of prostate cancer.

- Previous prostate surgery.

- Inability to urinate requiring the need of a catheter during the previous 2 years.

- Any condition (other than benign prostatic hypertrophy) which may result in urinary
symptoms or changes in urine flow rate.

- Cancer within previous 5 years (other than basal or squamous cell cancers of the
skin).

- Any unstable serious medical condition.

- Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride
(Avodart), testosterone, or drugs that can block the action of male hormones.
ПолMale
Минимальный возраст50 Years
Максимальный возраст75 Years
УсловиеNeoplasms, Prostate
Применяемое лечение
DrugDutasteride
DrugPlacebo
Контакты и расположение
Dnepropetrovsk , 49005GSK Investigational Site
Kharkiv , 61037GSK Investigational Site
Odesa , 65074GSK Investigational Site
Zaporizhzhya , 69103GSK Investigational Site
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