Tadalafil in Subjects With Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00157326
First received: September 8, 2005
Last updated: October 23, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Hypertension
Drug: tadalafil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Enrollment: 180
Study Start Date: September 2005
Study Completion Date: June 2006
Intervention Details:
    Drug: tadalafil
    Other Names:
    • LY450190
    • Cialis
    • IC351
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157326

Locations
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
Investigators
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00157326     History of Changes
Other Study ID Numbers: 10077, H6D-MC-LVGU
Study First Received: September 8, 2005
Last Updated: October 23, 2007
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Eli Lilly and Company:
High Blood Pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Tadalafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 18, 2014