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

• Conditions: mild essential hypertension

• Registration Number: EUCTR2005-004966-17-SE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

[1] Are men and women =18 and =70 years of age.
[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)
• CBPM range for untreated patients is SBP 140 to 159 mm Hg and/or DBP 90 to 99 mm Hg.
• CBPM range for patients on antihypertensive monotherapy is SBP 130 to 150 mm Hg and/or DBP 85 to 95 mm Hg.
[4] Have two mean CBPM (calculated using the last two of three readings) (SBP 140 to 159 mm Hg and/or DBP 90 to 99 mm Hg) during Study Period 2 (use mean CBPM readings from either of the following: Visit 2 and Visit 4 OR Visit 3 and Visit 4).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[5] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[6] Are Lilly employees.
[7] Have planned or are likely to require major surgery during the course of the study.
[8] Have any other medical condition, laboratory abnormality, or circumstance prior to randomization, which, in the opinion of the investigator, could affect patient safety, preclude evaluation of response on similar activity days throughout the trial, prohibit the ability to comply with study procedures and restrictions, or completion of the study (for example, swing-shift working conditions).
[9] Women of child-bearing potential who do not agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of study drug.
[10] Pregnant or nursing women. Women not surgically sterilized and between menarche and 1 year post menopause must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.
[11] Are unable, unreliable, and/or unwilling to provide informed consent, make themselves available for the duration of the study, or will not abide by the procedures and study restrictions.
[12] Have any other condition, which in the opinion of the investigator, precludes the patient from providing informed consent, following the protocol procedures and restrictions, or completing the protocol.
[13] Have secondary or malignant hypertension.
[14] Have or have had a history of hyperlipidemia within 3 months of screening requiring treatment according to ESH/ESC guidelines (ESH-ESC 2003).
[15] Have any previous CV disease other than hypertension.
[16] Have type 1 or 2 diabetes mellitus.
[17] Have a body mass index (BMI) >35 kg/m2.
[18] Have a history of symptomatic postural hypotension or postural dizziness.
[19] Patient-reported history of human immunodeficiency virus (HIV) infection.
[20] Have or have had a history of a chronic muscular or neuromuscular disease, including a history of prior rhabdomyolysis, drug-induced myopathy (for example, statin or fibric acid), or an unexplained elevation in CK = 3 x ULN.
[21] Are currently under suspicion of having cancer or have had a history of cancer in the past 2 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
[22] Have chronic alcohol or drug abuse or dependency.
[23] Currently adhering to, have used within 2 months prior to screening, or have plans to adopt diets with aggressive carbohydrate restrictions for weight loss, such as, but not limited to, Atkins or South Beach diets.
[24] Currently use, have used within 2 months prior to screening, or plan to use during the trial period dietary supplements or over the counter formulations intended for weight loss.
[25] Have active hepatobiliary disease, serologic evidence of past or active hepatitis B or C, or active gallbladder disease.
[26] Liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], or total bilirubin >1.5x the upper limit of normal [ULN]).
[27]

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified