mild essential hypertension
Conditions
Interventions
Product Name: LY518674
Pharmaceutical Form: Capsule*
Current Sponsor code: LY518674
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
Current Sponsor code: LY5186
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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
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]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to test the hypothesis that LY518674, administered for 6 weeks to patients with mild essential hypertension, reduces 24-hour mean ambulatory SBP, compared with placebo.;Secondary Objective: •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 and 8-hour awake period •Compare the effect of LY518674 on CBPM SBP and DBP with that of placebo. •Determine the percentage of responders to LY518674 •Evaluate the effects of LY518674, relative to placebo, on plasma levels of total TC, LDL-C, HDL-C, TG and hsCRP •Evaluate the safety and tolerability effects of LY518674 ---Additional Objective • Blood pressure and safety evaluations associated with the primary and secondary objectives ---Specific to Sample Banking -associating naturally occurring differences in the serum or plasma or DNA with risk for diseases -identifying genetic or protein biomarkers related to the therapeutic response to LY518674 or other compounds;Primary end point(s): Change (mm Hg) in mean 24-hour ambulatory SBP from baseline to study end. | — |
Countries
Sweden
Outcome results
None listed