Hypertension
Conditions
Keywords
High Blood Pressure
Brief summary
Purpose: The primary objective of this study is to evaluate the efficacy and safety of tadalafil when administered once daily at doses of 5 and 20 mg to adult subjects for 8 weeks with mild to moderate hypertension.
Interventions
DRUGtadalafil
Sponsors
ICOS Corporation
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be assessed by evaluating all reported adverse events and changes in clinical laboratory values, ECGs, and vital signs | — |
Countries
United States
Outcome results
None listed