NCT00374855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

May 15, 2007

Status Verified

May 1, 2007

First QC Date

September 8, 2006

Last Update Submit

May 11, 2007

Conditions

Mild Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

PPAR alphaDRUG
HydrochlorothiazideDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

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

Åmål, SE66230, Sweden

Location

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

Falköping, 52143, Sweden

Location

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

Gothenburg, SE 41137, Sweden

Location

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

Järfälla, 17731, Sweden

Location

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

Luleå, 97233, Sweden

Location

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

Malmo, SE 21137, Sweden

Location

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

Mönsterås, SE 38321, Sweden

Location

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

Rättvik, SE 79530, Sweden

Location

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

Skellefteå, SE 93132, Sweden

Location

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, 13323, Sweden

Location

Related Links

MeSH Terms

Interventions

PPAR alphaHydrochlorothiazide

Intervention Hierarchy (Ancestors)

Peroxisome Proliferator-Activated ReceptorsReceptors, Cytoplasmic and NuclearProteinsAmino Acids, Peptides, and ProteinsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 12, 2006

Study Start

September 1, 2006

Study Completion

November 1, 2006

Last Updated

May 15, 2007

Record last verified: 2007-05

Locations

SE(10)