Tadalafil in Subjects With Mild to Moderate Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157326
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 25, 2007
ICOS Corporation
Information provided by:
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: tadalafil Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Intervention Details:
  • Drug: tadalafil
    Other Names:
    • LY450190
    • Cialis
    • IC351

Primary Outcome Measures :
  1. 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 :
  1. Safety will be assessed by evaluating all reported adverse events and changes in clinical laboratory values, ECGs, and vital signs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157326

United States, Washington
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
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Study Director: 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

Additional Information: Identifier: NCT00157326     History of Changes
Other Study ID Numbers: 10077
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: October 2007

Keywords provided by Eli Lilly and Company:
High Blood Pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents