Clinical trial NCT00374855: A Study in People With Mild Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Hypertension
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-09-12
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: 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
measure: 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
measure: 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
measure: Compare the effect of LY518674 on CBPM SBP and DBP with that of placebo
measure: 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
measure: 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)
measure: Evaluate the safety and tolerability effects of LY518674, relative to placebo, in patients with mild hypertension
Other outcomes:
Locations:
city: Amal
country: Sweden
facility: 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
city: Falkoping
country: Sweden
facility: 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
city: Göteborg
country: Sweden
facility: 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
city: Järfälla
country: Sweden
facility: 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
city: Lulea
country: Sweden
facility: 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
city: Malmo
country: Sweden
facility: 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
city: Monsteras
country: Sweden
facility: 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
city: Rattvik
country: Sweden
facility: 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
city: Skelleftea
country: Sweden
facility: 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
city: Stockholm
country: Sweden
facility: 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
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST
role: STUDY_DIRECTOR
References: