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A Study in People With Mild Hypertension


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  • Purpose

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    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.


    status: completed
    conditions: Mild Hypertension
    interventions: PPAR alpha ; Hydrochlorothiazide ; Placebo
    phase: Phase 2
    study type: Interventional
    study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
    official title: Protocol H8D-MC-EMBH PPAR Alpha (LY518674): a Phase 2 Dose-Response Study to Evaluate the Blood Pressure-Lowering Effect in Essential Hypertension

  • Further study details (as provided by Eli Lilly and Company)

    primary outcome measures:

    • 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:

    • 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

    enrollment: 153

    study start date: September 2006

    study completion date: November 2006


  • Eligibility

    ages eligible for study: 18 Years to 70 Years
    genders eligible for study: Both

    Criteria

    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

  • Contacts and locations

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00374855

    Locations

    Sweden  - 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

    facility: Malmo, Sweden, SE 21137

    Sweden  - 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

    facility: Monsteras, Sweden, SE 38321

    Sweden  - 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

    facility: Rattvik, Sweden, SE 79530

    Sweden  - 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

    facility: Skelleftea, Sweden, SE 93132

    Sweden  - 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

    facility: Stockholm, Sweden, 13323

    Sweden  - 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

    facility: Amal, Sweden, SE66230

    Sweden  - 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

    facility: Falkoping, Sweden, 52143

    Sweden  - 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

    facility: Göteborg, Sweden, SE 41137

    Sweden  - 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

    facility: Järfälla, Sweden, 17731

    Sweden  - 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

    facility: Lulea, Sweden, 97233

  • Sponsors and collaborators

    Eli Lilly and Company

    investigators: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST, Study Director, Eli Lilly and Company

  • More information

    Lilly Clinical Trial Registry

    first received: September 8, 2006
    last updated: May 11, 2007
    ClinicalTrials.gov Identifier: NCT00374855
    health authority: United States: Food and Drug Administration

Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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