Status:
COMPLETED
Diuretics In the Management of Essential Hypertension (DIME) Study
Lead Sponsor:
Kyoto University
Collaborating Sponsors:
University of the Ryukyus
Conditions:
Hypertension
Eligibility:
All Genders
30-79 years
Phase:
PHASE4
Brief Summary
The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. Th...
Detailed Description
There has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension. Diuretics may be more effective in reduction of ...
Eligibility Criteria
Inclusion
- Aged 30 to 79 years
- With blood pressure being \>150/\>90 if they are not on any antihypertensive treatment
- With blood pressure being \>140/\>90 if they are already on antihypertensive drugs
- No history of type 2 diabetes
- No history of gout
Exclusion
- With supine blood pressure being \>200/\>120
- Patients already on antihypertensive treatment if duration of treatment and drugs used are not identified
- Patients already on thiazide diuretics
- With type 2 diabetes
- With gout or hyperuricaemia (\>8.0 mg/dl)
- With hypokalemia（\<3.5mmol/L）
- With erectile dysfunction
- With renal dysfunction (s-creatinine \> 2.0 mg/dL)
- With history of serious adverse reaction to thiazide diuretics
- With history of stroke or myocardial infarction within 6 months
- With history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 6 months or in whom these interventions are planned
- With heart failure or left ventricular dysfunction (ejection fraction\<40%)
- Patients who should be on thiazide diuretics
- With history of malignant tumor within 5 years
- Pregnant, possibility of pregnancy, or during breast feeding
- Patients who are deemed not eligible for this study for any reason
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
1130 Patients enrolled
Trial Details
Trial ID
NCT00131846
Start Date
April 1 2004
End Date
November 1 2013
Last Update
June 14 2024
Active Locations (1)
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1
University of the Ryukyus
Nishihara, Okinawa, Japan, 903-0215