Purpose: The primary objective of this study is to evaluate the efficacy and safety of tadalafil when adminstered once daily at doses of 5 and 20 mg to adult subjects for 8 weeks with mild to moderate hypertension.

Condition	Intervention	Phase
Hypertension	Drug: tadalafil	Phase II

Further Study Details: 

Primary Outcomes: 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 Outcomes: Safety will be assessed by evaluating all reported adverse events and changes in clinical laboratory values, ECGs, and vital signs
Expected Total Enrollment:  171

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Have a documented medical history of hypertension.
• Have cuff seated diastolic blood pressure values ≥ 95 and ≤ 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) ≥ 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) ≥ 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00157326

Jeffrey Wood      425-415-2262 

Washington
      For additional information regarding investigational sites for this trial call central contact, Bothell,  Washington,  98021,  United States; Recruiting

Study chairs or principal investigators

Mack Mabry, MD,  Study Chair,  ICOS   

Study ID Numbers:  H6D-MC-LVGU
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00157326
Health Authority: United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13