Hypertension
Conditions
Interventions
1) The subjects switch lower dose of ARB to ACE inhibitor "
Lenimec"
5mg, or higher dose of ARB to Lenimec 10mg. Both groups take one tablet at a time, once a day. 2) The target level of hypotensive effect will be the blood pressure (hospital) measured at the beginni
Fluitran"
Sponsors
Kanetsu hospital
Laboratory of Pharmaceutical Regulatory Science, School of Pharmacy, Nihon University Cyber Cross Japan, Ltd. SRL, Ltd. School of Medicine, Showa University Graduate school of Medicine, Tokyo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patients who have only taken ARB over half year 2) The patients who have taken ARB by usual dosage 3) The patients with essential hypertension whose blood pressure is under control within SBP < 160mmHg and/or DBP < 100mmHg 4) The patients who are able to use a sphygmomanometer with data transfer function 5) The patients who are able to use PHS communication network at the location of home blood pressure measurement 6) The patients who do not take the supplements or the health foods which an effect on blood pressure improving metabolic syndrome suggests, or are based on a mineral such as calcium during study period. 7) Outpatients. 8) The subjects who submit the informed consent of this study
Exclusion criteria
Exclusion criteria: 1) The patients who will take antihypertensive drugs except ARB or ACE inhibitor 2) The patients who have already changed to ARB by the adverse effects (dry cough) of ACE inhibitor 3) The patients who are class II and III hypertension 4) The secondary hypertension patients. 5) The patients with stroke, myocardial infarction and serious vascular disease to require hospitalization within six months 6) The patients with hepatic dysfunction (the levels of AST (GOT) and ALT (GPT) exceed 3 times of the standard value (facility criteria).) 7) The patients with renal dysfunction 8) The patients with heart failure over NYHA III 9) The patients with malignancy and poor-prognosis critical disorders. 10) The patients with history of angioedema. 11) The patients who have been treated with the apheresis system using a dextran sulfate immobilized cellulose, a tryptophan immobilized polyvinyl alcohol or a polyethylene terephthalate 12) The patients on hemodialysis with membrane using acrylonitrile methallyl sulphonate. 13) The patients with anuria. 14) The patients who decrease in sodium and potassium in the body fluid. 15) Female patients who are pregnant or hope for pregnancy during the research. 16) The patients with history of hypersensitivity to enalapril, thiazide drugs, or analogous compound. 17) The patients who judged the principal investigator (or the subinvestigators) to be inappropriate from a medical base
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of keeping the blood pressure by Lenimec compared with the first time of switching from ARB to Lenimec 1. The amount and the rate of change of the blood pressure (hospital and home) 2. The rate of the subjects who can switch from ARB to Lenimec 5mg only 3. The rate of the subjects who increase Lenimec 10mg from 5mg and have completed a switch. 4. The rate of the subjects who first start switching Lenimec 10mg and have completed a switch | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of keeping the blood pressure by Lenimec + Fluitran compared with the first blood pressure of switching from ARB to Lenimec | — |
Countries
Japan
Contacts
Public ContactMotoki Arakawa
School of Pharmacy, Nihon University Laboratory of Pharmaceutical Regulatory Science
Outcome results
None listed