A Study in People With Mild Hypertension

Phase 2

Completed

• Conditions: Mild Hypertension

• Registration Number: NCT00374855
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The primary objective of this study is to test the hypothesis that LY518674, administered for 6 weeks to patients with mild hypertension, reduces Systolic Blood Pressure, compared with placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-12
• Study Completion: 2006-11
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-11
• Last Update Posted: 2007-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

1. Are men and women between 18 and 70 years of age, inclusive
2. Have given signed informed consent to participate in this study
3. Are diagnosed with mild essential hypertension at screening (currently untreated or treated with monotherapy)

Exclusion Criteria

1. Secondary or malignant hypertension
2. Have or have had a history of hyperlipidemia within 3 months of screening requiring treatment
3. Any previous cardiovascular disease other than hypertension
4. Type 1 or 2 diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To test the hypothesis that LY518674, administered for 6 weeks to patients with mild hypertension, reduces 24-hour mean ambulatory Systolic Blood Pressure, compared with placebo.

Secondary Outcome Measures

Name	Time	Method
Determine the duration and consistency of the reduction in BP over the course of a day, relative to placebo, after 6 weeks of treatment with LY518674 when taken once daily
Evaluate the population dose and exposure response relationships of LY518674 for lowering the mean SBP and DBP during the 24 hour period, using ABPM during a 6 week treatment period
Evaluate the population dose, exposure, and time response relationships of LY518674 for lowering the mean SBP and DBP during the 8 hour awake period, using ABPM during a 6 week treatment and following cessation of dosing
Compare the effect of LY518674 on CBPM SBP and DBP with that of placebo
Determine the percentage of responders to LY518674, relative to placebo, as defined by patients who achieve target BP goals of CBPM SBP <140 mm Hg and/or DBP 90 mm Hg, or a CBPM SBP decrease of at least 10 mm Hg
Evaluate the effects of LY518674, relative to placebo, on plasma levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), HDL-C, triglycerides (TG), and high-sensitivity C-reactive protein (hsCRP)
Evaluate the safety and tolerability effects of LY518674, relative to placebo, in patients with mild hypertension

Trial Locations

Locations (1)

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. test; 🇸🇪 Stockholm, Sweden