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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00157326 |
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Date of registration:
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08/09/2005 |
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Primary sponsor: |
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Public title:
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Tadalafil in Subjects With Mild to Moderate Hypertension
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Scientific title:
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A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Tadalafil (5mg and 20mg) Administered Once Daily to Subjects With Mild to Moderate Hypertension |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00157326 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have a documented medical history of hypertension.
- Have cuff seated diastolic blood pressure values greater than or equal to 95 and less
than or equal to 104 mm at study entry
- Have a negative serum pregnancy test at the time of enrollment and agree to use two
medically reliable methods of contraception until study completion, if female is of
child-bearing potential, between menarche and 1 year post menopause and not
surgically sterilized.
- Are able to comply with study procedures and visits
Exclusion Criteria:
- Have resistant hypertension or systolic hypertension.
- Are obese, defined as having body mass index (BMI) greater than or equal to 35.
- Are females who are pregnant or breast feeding.
- Have a history of severe renal insufficiency or significant thyroid, renal or hepatic
disease.
- Have a glycosylated hemoglobin A1c (HbA1c) greater than or equal to 10% during the
screening period.
- Have significant anemia.
- Have a significant or unstable cardiac history such as history of heart attack,
unstable angina, or stroke within 6 months of study entry, history of angina that was
treated with long- or short-acting nitrates within 90 days of study entry, history of
coronary artery bypass graft surgery or cardiac angioplasty within 90 days of study
entry, history of abnormal heart rhythms such as sick sinus syndrome or 2nd- or
3rd-degree AV block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia,
a history of recurrent ventricular tachycardia, or symptomatic bradycardia, a history
of sudden cardiac arrest.
- Have symptomatic heart failure requiring treatment, or significant disease of the
heart valves.
- Have been treated for severe asthma, bronchospasm, or COPD within 3 months of study
entry.
- Have severe peripheral vascular disease.
- Have a documented diagnosis of sleep apnea.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: tadalafil
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Primary Outcome(s)
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The primary efficacy measurement of this study is the mean change after 8 weeks of treatment from baseline in cuff seated trough diastolic blood pressure, cuff seated systolic blood pressures and automated blood pressure monitoring
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Secondary Outcome(s)
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Safety will be assessed by evaluating all reported adverse events and changes in clinical laboratory values, ECGs, and vital signs
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Secondary ID(s)
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10077
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H6D-MC-LVGU
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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