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

NCT ID: NCT00133185

Last Updated: 2013-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2005-03-31

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 reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

telmisartan 40 mg/hydrochlorothiazide 12.5 mg

Intervention Type: DRUG

losartan 50 mg/hydrochlorothiazide 12.5 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Male or female between 20 to 80 years old

3. Ability to provide written informed consent.

Exclusion Criteria

1. Patients are still taking more than three anti-hypertensives at the screening visit

2. Pre-menopausal women

3. Known or suspected secondary hypertension

4. Mean sitting DBP<95mmHg and/or mean sitting SBP > 200mmHg at the end of placebo run-in phase

5. Hepatic and/or renal dysfunction

6. Known bilateral renal artery stenosis, patient with a solitary kidney, post renal transplant

7. Known NYHA functional class Chronic Heart Failure (CHF) III, IV

8. Unstable angina, myocardial infarction, cardiac surgery or stroke within the preceding six months

9. Post-Transluminal Coronary Angioplasty(PTCA) within the preceding three months

10. 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

11. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.

12. Once documented evidence by ophthalmological examination of significant retinal haemorrhages/ exudates

13. Clinically significant sodium depletion as defined by serum sodium level less than 130 mmol/L

14. Clinically significant hyperkalemia as defined by serum potassium level >5.5 mmol/L

15. 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.

16. Insulin Dependent Diabetes Mellitus

17. Chronic administration of oral anticoagulants and/or digoxin within the past 6 months.

18. Known drug or alcohol dependency

19. Administration of medication known to affect blood pressure, except medication allowed by the protocol

20. Angioedema with ACE inhibitors

21. Use of nitrates

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Taiwan Ltd.

Locations

Machay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

502.406

Identifier Type: -

Identifier Source: org_study_id