Efficacy Study of VA106483 in Males With Nocturia. - NCT01038843-76017 (Clinical Trial 463412)
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| City: |
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Arlington |
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State:
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TX |
| Zip Code: |
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76017 |
| Conditions: |
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Nocturia |
| Purpose: |
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To investigate the effect of VA106483 on nocturia related clinical outcomes compared to
placebo.
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| Study summary: |
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Nocturia, defined as waking to urinate at least once per night between periods of sleep, is
a common complaint which increases with age. VA106483 is a non-peptide drug VA106483 that
is being developed for the treatment of nocturia in males.
The purpose of this study is to investigate the effect of VA106483 on the number of times
the subject needs to get up to urinate (nocturnal void) per night and to determine the
effect on the time between the subject's bedtime and the time they first wake up to urinate. |
| Criteria: |
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Inclusion Criteria:
- Male subjects aged ≥18 years (no upper limit) with nocturia
- Generally well (concomitant illness/conditions well controlled)
- Serum sodium within the normal limits
- Normal or not clinically significant prostate specific antigen levels
- Able to comply with the requirements of the study
- Provide written informed consent
Exclusion Criteria:
- Prostatic cancer
- Signs or symptoms of heart failure
- Peripheral pitting oedema extending ≥10 cm above the ankle
- Palpable bladder or pelvic mass on abdominal examination
- Enuresis or night-time incontinence
- Excessive nocturnal void frequency
- Sleep disorders
- Diabetes insipidus or uncontrolled diabetes mellitus
- Presence of blood or glucose in the urine on urinalysis that is clinically
significant
- Urinary tract infection
- Polydipsia
- Syndrome of inappropriate antidiuretic hormone secretion
- Body mass index ≥35
- High calcium levels or low potassium levels
- Other protocol defined eligibility criteria may apply |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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