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

• ClinicalTrials.gov Identifier: NCT00133185
• Recruitment Status: Completed
• First Posted: August 23, 2005
• Last Update Posted: November 19, 2013
• Sponsor: Boehringer Ingelheim
• Information provided by: Boehringer Ingelheim

Tracking Information

• First Submitted Date: August 22, 2005
• First Posted Date: August 23, 2005
• Last Update Posted Date: November 19, 2013
• Study Start Date: March 2004
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 2, 2009): Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase. [ Time Frame: 8 weeks ]
• Original Primary Outcome Measures (submitted: August 22, 2005): Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase.
• Current Secondary Outcome Measures (submitted: March 2, 2009): Change from baseline in sitting SBP, standing DBP, standing SBP, sitting and standing heart rate at trough as well as blood pressure control and blood pressure response as defined in study protocol at the last observation will be evaluated. [ Time Frame: 8 weeks ]
• Original Secondary Outcome Measures (submitted: August 22, 2005): Change from baseline in sitting SBP, standing DBP, standing SBP, sitting and standing heart rate at trough as well as blood pressure control and blood pressure response as defined in study protocol at the last observation will be evaluated.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5 mg in Comparison With Losartan 50 mg Plus Hydrochlorothiazide 12.5 mg in Taiwanese Patients With Mild to Moderate Hypertension
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• Drug: telmisartan 40 mg/hydrochlorothiazide 12.5 mg
• Drug: losartan 50 mg/hydrochlorothiazide 12.5 mg

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: November 18, 2013): 31
• Original Enrollment (submitted: August 22, 2005): 40
• Study Completion Date: March 2005
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT00133185
• Other Study ID Numbers: 502.406
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim Study Coordinator; B.I. Taiwan Ltd.

• PRS Account: Boehringer Ingelheim
• Verification Date: November 2013