NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-111486

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment20/4/2011
Target sample size600
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : AJH801 Dosage And administration of the intervention : Oral Control intervention name : Cilnidipine INN of the control intervention : Cilnidipine Dosage And administration of the control intervention : Oral Control intervention name : Valsartan INN of the control intervention : Valsartan Dosage And administration of the control intervention : Oral

Outcome(s)

Primary OutcomeReduction of sitting SBP and DBP at trough from baseline
Secondary Outcome- Blood pressure change - Antihypertensive efficacy ratio - Blood pressure controlling ratio

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteriaIn 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.
Exclude 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

Related Information

Contact

public contact
Name Ajinomoto Pharmaceuticals Co., Ltd Corporate Planning Dept.
Address contact_ajis@ajinomoto.com
Telephone
E-mail
Affiliation
scientific contact
Name Ajinomoto Pharmaceuticals Co., Ltd Corporate Planning Dept.
Address contact_ajis@ajinomoto.com
Telephone
E-mail
Affiliation