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OpenTrials
Completed

NCT Number: NCT00374855

A Study in People With Mild Hypertension

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.

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Key information

Conditions

Mild Hypertension

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary 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, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

PPAR alpha

Drug

Hydrochlorothiazide

Drug

Placebo

Drug

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

  1. 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

  2. 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

  3. 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

  4. Compare the effect of LY518674 on CBPM SBP and DBP with that of placebo

  5. 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

  6. 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)

  7. Evaluate the safety and tolerability effects of LY518674, relative to placebo, in patients with mild hypertension

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Protocol H8D-MC-EMBH PPAR Alpha (LY518674): a Phase 2 Dose-Response Study to Evaluate the Blood Pressure-Lowering Effect in Essential Hypertension

Important dates

Study start
2006
Study completion
2006
First posted
Sep 12, 2006
Registry last updated
May 15, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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