A Study in People With Mild Hypertension

Eli Lilly and Company153 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

153

Conditions

Mild Hypertension

Interventions

PPAR alphaDRUG

HydrochlorothiazideDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (10)

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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Åmål, Sweden

Falköping, Sweden

Gothenburg, Sweden

Järfälla, Sweden

Luleå, Sweden

Malmo, Sweden

Mönsterås, Sweden

Rättvik, Sweden

Skellefteå, Sweden

Stockholm, Sweden