Status:
COMPLETED
A Randomized, Double-blind, Parallel-group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Moderate Hypertension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a ref...
Eligibility Criteria
Inclusion
- Mild to moderate hypertension as defined by a morning mean(\>95 and \<115mmHg) of two diastolic blood pressure measurements (DBP) after 5 min in the sitting position following a minimum 2-week placebo run in phase.Mean sitting systolic blood pressure (SBP) must be \>140 and \<200mmHg. The mean DBP and SBP values are calculated as the mean of the two sitting measurements taken 2 min apart just before the drug intake.
- Male or female between 20 to 80 years old
- Ability to provide written informed consent.
Exclusion
- Patients are still taking more than three anti-hypertensives at the screening visit
- Pre-menopausal women
- Known or suspected secondary hypertension
- Mean sitting DBP\<95mmHg and/or mean sitting SBP \> 200mmHg at the end of placebo run-in phase
- Hepatic and/or renal dysfunction
- Known bilateral renal artery stenosis, patient with a solitary kidney, post renal transplant
- Known NYHA functional class Chronic Heart Failure (CHF) III, IV
- Unstable angina, myocardial infarction, cardiac surgery or stroke within the preceding six months
- Post-Transluminal Coronary Angioplasty(PTCA) within the preceding three months
- Sustained ventricular tachycardia, atria fibrillation, second or third degree AV block, VPC or APC (\>10% of heart rate) or other clinically relevant cardiac arrhythmia as determined by the clinical investigator
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
- Once documented evidence by ophthalmological examination of significant retinal haemorrhages/ exudates
- Clinically significant sodium depletion as defined by serum sodium level less than 130 mmol/L
- Clinically significant hyperkalemia as defined by serum potassium level \>5.5 mmol/L
- Non-insulin dependent DM poorly controlled whicih is defined as HbA1c\>8% twice consecutively within 6 months and/or AC blood sugar\>180 mg/dl.
- Insulin Dependent Diabetes Mellitus
- Chronic administration of oral anticoagulants and/or digoxin within the past 6 months.
- Known drug or alcohol dependency
- Administration of medication known to affect blood pressure, except medication allowed by the protocol
- Angioedema with ACE inhibitors
- Use of nitrates
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00133185
Start Date
March 1 2004
End Date
March 1 2005
Last Update
November 19 2013
Active Locations (1)
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1
Machay Memorial Hospital
Taipei, Taiwan, 104