Skip to content

Impact of olmesartan on glucose metabolism in hypertensive patients receiving statin therapy

A Randomized, Active-Comparator controlled, 2-period, Crossover, Single-center Study to Assess the Impact of Olmesartan versus Candesartan on the Fasting Glucose Impairment in Hypertensive Patients Receiving Statin Therapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0005143
Enrollment
82
Registered
2020-06-17
Start date
2020-06-24
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The subject after drug wash-out period of Amlodipine for 2 weeks from the signed of consent, they are assigned to a group based on a separate random allocation table, 'taking of Olmesartan with

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients must agree to the study protocol and provide written informed consent 2. Outpatients = 20 years of age, male or female 3. Non-diabetic patients with glucose intolerance (100140/90 mmHg without any antihypertensive drugs >120/80 mmHg with antihypertensive drugs 5. Hyperlipidemia patients who met the following criteria (At randomization) 1). one cardiovascular risk factor or the 10-year ASCVD risk 130mg/dL 2). two or more cardiovascular risk factors or the 10-year ASCVD risk >10%: LDL >100mmHg * Cardiovascular risk factors: (1) Male >45 years old, Female >55 years old (2) Family history of premature cardiovascular disease (first relatives male 140/90mmHg or anti-hypertensives user)

Exclusion criteria

Exclusion criteria: 1. Known patients with recent acute coronary syndrome within 3 months, myocardial infarction, ischemic stroke, peripheral artery disease, carotid artery disease, abdominal aneurysm or diabetic mellitus (Major atherosclerotic cardiovascular events) 2. Patients receiving treatment that could potentially affect glucose metabolism, including corticosteroids, diuretics, beta-blocker, oral hypoglycemic agents, lipid therapy other than rosuvastatin 3. History of hypersensitivity or allergy to the study drug, drugs of similar chemical classes, or ARB as well as known or suspected contraindications to the study drug 4. Current acute decompensated heart failure or dyspnea of NYHA functional class IV 5. Medical history of hospitalization for heart failure within 6 weeks 6. Substantial myocardial ischemia requiring coronary revascularization or a plan of coronary revascularization within 1 year 7. Symptomatic hypotension and/or a SBP < 100 mmHg at screening 8. Estimated GFR < 30 mL/min/1.73m2 9. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x upper limit of normal (ULN) at the screening visit (Visit 0), history of hepatic encephalopathy, history of esophageal varices, or history of the portacaval shunt. 10. History of severe pulmonary disease 11. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a barrier method plus a hormonal method 12. Pregnant or nursing (lactating) women 13. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study

Design outcomes

Primary

MeasureTime frame
The effect of candesartan versus olmesartan on beta cell function after 16-week treatment.

Secondary

MeasureTime frame
The effect of candesartan versus olmesartan on insulin sensitivity;The effect of candesartan versus Olmesartan on fasting plasma glucose, insulin, C-peptide and HbA1c after 16-week treatment;Changes of ACE2 and Ang-(1-7) level from baseline to 16 weeks in each treatment group

Countries

Korea, Republic of

Contacts

Public ContactDae-Hee Kim

Asan Medical Center

daehee74@amc.seoul.kr+82-2-3010-1597

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026