Tadalafil in Subjects With Mild to Moderate Hypertension | NCT00157326

Studies
Tadalafil in Subjects With Mild to Moderate Hypertension

NCT00157326

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Oct 25, 2007Estimated

Enrollment

180Actual

Phase

Phase 2

Conditions

Hypertension

Interventions

tadalafil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H6D-MC-LVGU

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2007

Last Update Posted Date

Oct 25, 2007Estimated

Name	Class
ICOS Corporation	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Name	Type	Description	Arm Group Labels	Other Names
tadalafil	Drug			LY450190 Cialis IC351

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Safety will be assessed by evaluating all reported adverse events and changes in clinical laboratory values, ECGs, and vital signs

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds