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AJH801 Phase III Comparative Clinical Study in individuals with essential hypertension

AJH801 Phase III Comparative Clinical Study in individuals with essential hypertension

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221447
Enrollment
600
Registered
2011-04-27
Start date
2011-04-27
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

investigational material(s) Generic name etc : AJH801 INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : Oral

Sponsors

Ajinomoto Pharmaceuticals Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In observation period -140 mmHg < the sitting SBP at trough < 199 mmHg - 90 mmHg < the sitting DBP at trough < 114 mmHg At the end of observation period -150 mmHg < the sitting SBP at trough < 199 mmHg - 95 mmHg < the sitting DBP at trough < 114 mmHg The difference in observation period -The difference between the sitting trough SBP at 2 points in observation period is within 30 mmHg. -The difference between the sitting trough DBP at 2 points in observation period is within 15 mmHg.

Exclusion criteria

Exclusion criteria: - Females who are pregnant, are breast-feeding, are potentially pregnant, are planning to be pregnant during the study period - Patients with secondary hypertension, or suspected of having secondary hypertension - Significant heart, renal, hepatic diseases or significant cerebrovascular disorder

Design outcomes

Primary

MeasureTime frame
Reduction of sitting SBP and DBP at trough from baseline

Secondary

MeasureTime frame
- Blood pressure change - Antihypertensive efficacy ratio - Blood pressure controlling ratio

Outcome results

None listed

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