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Randomized controlled trail on efficacy and safety of ARB and losartan potassium/Hydrochlorothiazide in hypertension patients

Randomized controlled trail on efficacy and safety of ARB and losartan potassium/Hydrochlorothiazide in hypertension patients - ABC study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009266
Enrollment
200
Registered
2012-11-10
Start date
2008-03-10
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Hypertension

Interventions

Losartan/HCTZ ARB/Calsium antagonist

Sponsors

Executive office of ABC study
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The inclusion criteria for study patients: 1) Hypertension Patient who has previously been treated with ARB normal dose*1 monotherapies at least for 1 months and whose blood pressure has not been adequately controlled*2 *1 ARB normal dose: Losartan 50 mg, Candesartan 8 mg, Valsartan 80 mg, Telmisartan 40 mg, Olmesartan 20 mg. *2 BP Target SBP < 140 mmHg and DBP < 90 mmHg (DM or CKD : SBP < 130 mmHg and DBP < 80 mmHg) 2) Patient of between 20 and 74 years of age 3) Both genders is included 4) In and out patients 5) Patient who understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Patients with IDDM 2) Patients with nephropathy (urinary albumin-to-creatinine ratio > 300mg/gCr) 3) Patients with poor controlled diabetes mellitus (HbA1c > 10.0%) 4) Patients during insulin treatment 5) Patients with poor controlled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) 6) Patients with malignant hypertension 7) Patients with a critical liver damage (ALT or AST is over 3 times of normal) 8) Patients with attack of gout in past 9) Patient has had any severe cardiovascular events with hospitalization within the 6 months prior to informed consent. 10) Patient is pregnant or breast feeding, or is a female expecting to conceive within the projected duration of the study. 11) Patients with the secondary hypertension 12) Patients with non-diabetic nephropathy such as chronic glomerulonephritis, polycystic nephropathy and reniculus etc. 13) Patients with heart failure (above NYHA grade III) 14) Patient has poor controlled arrhythmia 15) Patients has treated with diuretic 16) Patients has allergia of test drugs 17) Patients who are considered to be not eligible to the study by the investigator due to medical reasons.

Design outcomes

Primary

MeasureTime frame
Change of serum-lipids, apolipoproteins and inflammation marker in all trial period within 2 groups. Serum-lipids: Total cholesterol, Triglyceride, HDL-C, LDL-C Apolipoprotein: apo-AI, apo-B, apo-E Inflammation marker: hs-CRP

Secondary

MeasureTime frame
Change of Blood pressure and eGFR in all trial period within 2 groups. Change of FBS, HbA1c, S-Cr, S-Na, S-K, and Uric acid.

Countries

Japan

Contacts

Public ContactHiroshi Hosoai

Executive office of ABC study Representation

hiroshi@hosoai.com0333485791

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026