Tadalafil in Subjects With Mild to Moderate Hypertension
This study has been completed.
Information provided by:
Eli Lilly and Company
First received: September 8, 2005
Last updated: October 23, 2007
Last verified: October 2007
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 Outcome Measures:
- Safety will be assessed by evaluating all reported adverse events and changes in clinical laboratory values, ECGs, and vital signs
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157326
|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
|Bothell, Washington, United States |
Eli Lilly and Company
||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)
||Eli Lilly and Company
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2005
||October 23, 2007
||United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Eli Lilly and Company:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Phosphodiesterase 5 Inhibitors
Molecular Mechanisms of Pharmacological Action