anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Testosterone
Trial phase: Not Applicable
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Postmenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.
Eligibility criteria:
Inclusion Criteria:

Women aged 18-75 years and men 45-75 years
Healthy lean, overweight and obese women (BMI 18-40 kg/m2) and obese men (BMI 30-40 kg/m2)
Obese women (BMI 30-40 kg/m2) with OSA or PCOS

Exclusion Criteria:

Pregnant, lactating, peri- or postmenopausal women will be excluded from the study because of potential confounding influences of these factors and potential ethical concerns (pregnant women)
Women taking medications known to affect substrate metabolism and those with evidence of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus, liver disease, hypo- or hyper-thyroidism) other than PCOS and OSA
Severe hypertriglyceridemia (fasting plasma TG concentration >400 mg/dl)
Subjects with OSA who have an apnea-hypopnea index (AHI) score >30 (the total number of obstructive events divided by the total hours of sleep) will be excluded and instructed to seek medical care
Intervention: Progesterone
Trial phase: Not Applicable
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Women with obesity and polycystic ovary syndrome

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.
Eligibility criteria:
Inclusion Criteria:

Women aged 18-75 years and men 45-75 years
Healthy lean, overweight and obese women (BMI 18-40 kg/m2) and obese men (BMI 30-40 kg/m2)
Obese women (BMI 30-40 kg/m2) with OSA or PCOS

Exclusion Criteria:

Pregnant, lactating, peri- or postmenopausal women will be excluded from the study because of potential confounding influences of these factors and potential ethical concerns (pregnant women)
Women taking medications known to affect substrate metabolism and those with evidence of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus, liver disease, hypo- or hyper-thyroidism) other than PCOS and OSA
Severe hypertriglyceridemia (fasting plasma TG concentration >400 mg/dl)
Subjects with OSA who have an apnea-hypopnea index (AHI) score >30 (the total number of obstructive events divided by the total hours of sleep) will be excluded and instructed to seek medical care
Intervention: Progesterone
Trial phase: Not Applicable
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Postmenopausal women

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.
Eligibility criteria:
Inclusion Criteria:

Women aged 18-75 years and men 45-75 years
Healthy lean, overweight and obese women (BMI 18-40 kg/m2) and obese men (BMI 30-40 kg/m2)
Obese women (BMI 30-40 kg/m2) with OSA or PCOS

Exclusion Criteria:

Pregnant, lactating, peri- or postmenopausal women will be excluded from the study because of potential confounding influences of these factors and potential ethical concerns (pregnant women)
Women taking medications known to affect substrate metabolism and those with evidence of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus, liver disease, hypo- or hyper-thyroidism) other than PCOS and OSA
Severe hypertriglyceridemia (fasting plasma TG concentration >400 mg/dl)
Subjects with OSA who have an apnea-hypopnea index (AHI) score >30 (the total number of obstructive events divided by the total hours of sleep) will be excluded and instructed to seek medical care
Intervention: FLUTICASONE PROPIONATE
Trial phase: Not Applicable
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Lean and obese healthy women, and obese men

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.
Eligibility criteria:
Inclusion Criteria:

Women aged 18-75 years and men 45-75 years
Healthy lean, overweight and obese women (BMI 18-40 kg/m2) and obese men (BMI 30-40 kg/m2)
Obese women (BMI 30-40 kg/m2) with OSA or PCOS

Exclusion Criteria:

Pregnant, lactating, peri- or postmenopausal women will be excluded from the study because of potential confounding influences of these factors and potential ethical concerns (pregnant women)
Women taking medications known to affect substrate metabolism and those with evidence of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus, liver disease, hypo- or hyper-thyroidism) other than PCOS and OSA
Severe hypertriglyceridemia (fasting plasma TG concentration >400 mg/dl)
Subjects with OSA who have an apnea-hypopnea index (AHI) score >30 (the total number of obstructive events divided by the total hours of sleep) will be excluded and instructed to seek medical care
Intervention: Estradiol
Trial phase: Not Applicable
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Postmenopausal women

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.
Eligibility criteria:
Inclusion Criteria:

Women aged 18-75 years and men 45-75 years
Healthy lean, overweight and obese women (BMI 18-40 kg/m2) and obese men (BMI 30-40 kg/m2)
Obese women (BMI 30-40 kg/m2) with OSA or PCOS

Exclusion Criteria:

Pregnant, lactating, peri- or postmenopausal women will be excluded from the study because of potential confounding influences of these factors and potential ethical concerns (pregnant women)
Women taking medications known to affect substrate metabolism and those with evidence of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus, liver disease, hypo- or hyper-thyroidism) other than PCOS and OSA
Severe hypertriglyceridemia (fasting plasma TG concentration >400 mg/dl)
Subjects with OSA who have an apnea-hypopnea index (AHI) score >30 (the total number of obstructive events divided by the total hours of sleep) will be excluded and instructed to seek medical care
Intervention: Budesonide
Trial phase: Phase 2
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Intervention Arm
Eligibility criteria:
Inclusion Criteria:

Written, voluntary, informed consent given
18 years or older
Speak and read English
Extensive ulcerative colitis based upon endoscopy, histopathology, and clinical symptoms
SCCAI Score > 3
Presence of diarrhea (3 or more bowel movements per 24 hours) AND grossly visible blood in stool

Exclusion Criteria:

Serum creatinine > 2.0 mg/dL
Pregnant or breastfeeding
Prior history of total or subtotal colectomy, or currently has an ostomy
History or suspicion of Crohn's disease or Indeterminate colitis
Diagnosis of any condition deemed by the investigator inhibiting completion of the trial
Initiated therapy with or change in mesalamine dose within the last 4 weeks
Change in azathioprine, 6-mercaptopurine, or cyclosporine within the last 8 weeks
Currently taking or have used corticosteroids within the last 8 weeks
Rectally administered mesalamine or steroids within the last 2 weeks
Current or prior use of anti-TNF alpha agents within the last 8 weeks
Experimental ulcerative colitis agents within the last 8 weeks
Concomitant use of CYP3A4 activity inhibitor (e.g. ketoconazole, itraconazole, ritonavir, indinavir, erythromycin)
Uncontrolled diabetes (HgA1c > 8.0) within 1 year
Unstable Coronary artery disease/Class III/IV CHF
Decompensated cirrhosis (e.g. encephalopathy, renal failure, ascites, GIB)
Any known infection requiring antibiotics
Active Clostridium difficile infection
COPD requiring home oxygen
HIV/AIDS with CD4 < 200 or AIDs-defining illnesses/infections
Intervention: Tradipitant
Trial phase: Phase 2
SMILES: O=C(c1ccccc1Cl)c1cccnc1-c1nnn(Cc2cc(C(F)(F)F)cc(C(F)(F)F)c2)c1-c1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: 50 milligrams (mg) daily by oral route for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Have Alcohol Dependence.
Are men or women who are ambulatory outpatients between 21 to 65 years of age (inclusive) showing evidence of living in a non-custodial stable residence and with no plans to move during the next 5 months.
Females of childbearing potential (not surgically sterilized and between menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. They must agree to use a reliable method of birth control during the study and for 2 months following the last dose of study drug.
Drink on average more than 14 drinks (women) or 21 drinks (men) per week with at least 2 heavy drinking days per week.
Endorse abstinence or reduction in drinking as an interim goal toward abstinence.

Exclusion Criteria:

Are investigator site personnel directly affiliated with this study and/or their immediate families.
Are Lilly employees.
Are currently enrolled in or discontinued within the last 30 days from a clinical trial.
Have experienced an acute alcohol withdrawal syndrome within the past 6 months or are currently or during this study at significant risk of suffering an acute alcohol withdrawal syndrome.
Have a history of serious head injury, neoplasm or hemorrhage, prior seizure (other than a history of childhood febrile seizure), or other condition that would place the subject at increased risk for seizures.
Are taking or have taken anticonvulsant medications for seizures.
Are diagnosed with substance dependence or substance abuse other than alcohol, cannabis, nicotine, or caffeine within 12 months prior to first visit.
Are receiving medications or intensive behavioral or psychological therapy delivered by a licensed or certified alcohol treatment specialist for alcohol dependence.
Have signs and symptoms or an active illness within the past 2 weeks of first visit that meet criteria diagnosis of Major Depressive Disorder. In addition, meet criteria as diagnosis for any comorbid Axis I disorders (such as anxiety disorders, obsessive compulsive disorder (OCD), Posttraumatic stress disorder (PTSD), panic disorder, or dysthymia).
Have a positive urine drug screen for any non-prescribed substances of abuse.
Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality.
Ever had electroconvulsive therapy (ECT).
Have abnormal thyroid stimulating hormone (TSH) concentrations or are taking thyroid supplements.
Have a history of cirrhosis or laboratory evidence of hepatocellular injury.
An abnormality in serum Prothrombin time.
Are unable to make themselves available for the duration of the study or abide by study procedures and restrictions.
Intervention: Daptomycin
Trial phase: Not Applicable
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 200
Group description: Group of patients that will receive antibiotics 30-60 minutes prior to incision
Eligibility criteria:
Inclusion Criteria:

All Patients undergoing cesarean delivery

Exclusion Criteria:

Patients diagnosed with chorioamnionitis at the time of decision
Patients that require an emergency cesarean delivery
Patients that decline participating on the study
Intervention: Daptomycin
Trial phase: Not Applicable
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 200
Group description: Group of patients that will receive antibiotics immediately after clamping the umbilical cord
Eligibility criteria:
Inclusion Criteria:

All Patients undergoing cesarean delivery

Exclusion Criteria:

Patients diagnosed with chorioamnionitis at the time of decision
Patients that require an emergency cesarean delivery
Patients that decline participating on the study
Intervention: Thymidine
Trial phase: Phase 3
ATC code: J05AF11
SMILES: Cc1cn([C@@H]2C[C@@H](O)[C@H](CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 16
Group description: All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
Eligibility criteria:
Inclusion Criteria:

Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or HBsAg positive > 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc
Age < 40 years old
HBeAg positive
HBV DNA > or = to 10^7 copies/mL by Abbott real-time PCR
ALT < or = to 1 ULN
Willing and able to provide written informed consent
No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for HBV infection)
Is willing and able to comply with the study drug regimen and all other study procedures and requirements
Is willing and able to provide written informed consent before any study assessment is perform

Exclusion Criteria:

Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 × ULN, PT > 1.2 × ULN, platelets < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g. ascites, jaundice, encephalopathy, variceal hemorrhage).
Received interferon (pegylated or not) therapy within 6 months of the screening visit
α-fetoprotein > 50 ng/mL
Evidence of hepatocellular carcinoma (HCC)
Co-infection with HCV (by serology), or HIV,
Significant renal, cardiovascular, pulmonary, or neurological disease.
Received solid organ or bone marrow transplantation.
Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
Has proximal tubulopathy.
Use of other investigational drugs at the time of enrollment, or within 30 days
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Is pregnant or breastfeeding.
Is a women of child-bearing potential (WOCBP)unless post-menopausal or using one or more acceptable method of contraception.
Patient has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years.
Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Lovaza
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Lovaza, 3 grams/day for 65 days
Eligibility criteria:
Inclusion Criteria:

Healthy, free of disease
Must be able to swallow capsules
Free of orthopedic or muscular injuries
Recreationally active
Prior consumption of fish and corn with no adverse reactions

Exclusion Criteria:

Use of non-steroidal anti-inflammatory drugs (NSAIDS) or topical analgesics during study enrollment
Pregnant or nursing
Food allergy to fish or any components of the pills which includes alpha tocopherol, partially hydrogenated vegetable oils including soybean oils and gelatin and glycerol or wheat germ oil
Competitive athlete or physically active more than 10 hours per week
Intervention: CLOBETASOL PROPIONATE
Trial phase: Phase 2
ATC code: D07AD01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 22
Group description: Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
Eligibility criteria:
Inclusion Criteria:

at least one parent diagnosed with Atopic Dermatitis
one parent or sibling with hayfever or asthma

Exclusion Criteria:

newborns with dermatitis at birth
newborns born greater than four weeks prematurely
newborns with medical problems necessitating prolonged hospitalization
newborns diagnosed with any immune deficiency syndrome
Intervention: Metoprolol
Trial phase: Phase 4
ATC code: C07AB02 | C07BB02 | C07BB52 | C07CB02 | C07FB02 | C07FB13 | C07FX03 | C07FX05
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Receiving metoprolol

Metoprolol: Metroprolol tartrate titrated up
Eligibility criteria:
Inclusion Criteria:

Patients must have confirmed malignancy for which standard regimens of anthracyclines or trastuzumab are being offered as treatment at the University of Maryland Greenebaum Cancer Center. Patients must either receive 4 cycles of anthracycline for a total dose of 240 mg/m2 or six cycles of TAC for a total dose of 300 mg/m2 or trastuzumab.
Age > 18 years
Ability to understand and willingness to sign a written informed consent document.
Women of childbearing potential may participate in this study only if they have a negative pregnancy test and agree not to become pregnant during the study. Woman of childbearing potential must use an effective method of birth control such as hormonal contraceptives (oral and implant) condoms, diaphragms, spermicidal foam or jelly, surgical (hysterectomy or tubal ligation) or intrauterine device.

Exclusion Criteria:

Patients who have established dilated or restrictive cardiomyopathy with EF < 40 %.
Patients with severe mitral or aortic valve disease (valve area <1cm squared).
Patients who have any contraindication to metoprolol, in particular bradycardia with HR < 50, or severe reactive pulmonary disease such as asthma. Patients who take mibefradil or psychiatric drugs (such as phenothiazines including chlorpromazine and thioridazine) will also be excluded from the study as they have serious interactions with beta-blockers
Patients who have untreated thyroid function disorder.
Pregnant and nursing women are excluded from this study because of potential risk for adverse events to the fetus.
Patients with any impediment to swallowing tablets would be excluded.
Intervention: MK-0736
Trial phase: Phase 2
SMILES: CCS(=O)(=O)CCCC12CCC(c3nnc(-c4ccccc4C(F)(F)F)n3C)(CC1)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
Eligibility criteria:
Inclusion Criteria:

Must be 18 to 75 years of age
Type 2 Diabetes Mellitus (Glycohemoglobin [A1CHbA1c]: 7 to 10%)
Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood pressure (SBP; 120 to 159 mm Hg)
LDL-C < 140 mg/dL
On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

Exclusion Criteria:

History of Type I Diabetes mellitus or ketoacidosis
Patients taking 3 or more blood pressure lowering medications
Have severe chronic heart failure
History of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease
History of cancer within the last 5 years
Human immunodeficiency virus (HIV) Positive
Have received treatment with any investigational drugs within the past 30 days
History of alcohol or drug abuse within the past 3 years
Body Mass Index ( BMI) >= 41 kg/m2
Intervention: MK-0736
Trial phase: Phase 2
SMILES: CCS(=O)(=O)CCCC12CCC(c3nnc(-c4ccccc4C(F)(F)F)n3C)(CC1)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
Eligibility criteria:
Inclusion Criteria:

Must be 18 to 75 years of age
Type 2 Diabetes Mellitus (Glycohemoglobin [A1CHbA1c]: 7 to 10%)
Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood pressure (SBP; 120 to 159 mm Hg)
LDL-C < 140 mg/dL
On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

Exclusion Criteria:

History of Type I Diabetes mellitus or ketoacidosis
Patients taking 3 or more blood pressure lowering medications
Have severe chronic heart failure
History of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease
History of cancer within the last 5 years
Human immunodeficiency virus (HIV) Positive
Have received treatment with any investigational drugs within the past 30 days
History of alcohol or drug abuse within the past 3 years
Body Mass Index ( BMI) >= 41 kg/m2