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
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: telmisartan 40mg / hydrochlorothiazide 12.5mg (Drug); osartan 50mg / hydrochlorothiazide 12.5mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: B.I. Taiwan Ltd.
Summary
The primary objective of this trial is to compare the efficacy and safety of telmisartan 40mg
/ hydrochlorothiazide 12. 5mg (Micardis Plus) with that of losartan 50mg / hydrochlorothiazide
12. 5mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate
hypertension.
Clinical Details
Official title: A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40mg + HCTZ 12.5 mg in Comparison With Losartan 50mg + HCTZ 12.5 mg in Taiwanese Patients With Mild to Moderate Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase.
Secondary outcome: 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.
Detailed description:
This is a randomised, double-blind, double-dummy, parallel-group study in mild to moderate
hypertensive patients treated for eight weeks with either telmisartan 40mg /
hydrochlorothiazide 12. 5mg or losartan 50mg/ hydrochlorothiazide 12. 5mg.
The study will be divided into two phases:
(i) Placebo Run-in Phase (Visit 1 to Visit 2, day - 14 (~ day -21) to day 1): Initial
screening and withdrawal of current anti-hypertensives is followed by a two week placebo
phase with dummy telmisartan 40mg / hydrochlorothiazide 12. 5mg and dummy losartan 50mg /
hydrochlorothiazide 12. 5mg. Baseline assessments are done at the end of the 2 week run-in
phase (at Visit 2, day 1).
(ii) Treatment Phase (Visit 2 to 4, day 1 to day 57): This is an eight-weeks double-blind,
double-dummy parallel trial with telmisartan 40mg / hydrochlorothiazide 12. 5mg or losartan
50mg / hydrochlorothiazide 12. 5mg. Final assessments are done at the end of the eight-weeks
treatment phase at Visit 4.
Study Hypothesis:
Null and alternative hypothesis The change from baseline in sitting diastolic blood pressure
at trough (24 hours post-dosing) at the last visit during the double-blind phase defines the
primary endpoint. This trial is to test the non-inferiority of efficacy of telmisartan 40mg /
hydrochlorothiazide 12. 5mg to losartan 50mg / hydrochlorothiazide 12. 5mg. A difference of
3mmHg in reducing sitting diastolic blood pressure would be considered clinically
significant.
H0: (Reduction from baseline in sitting diastolic blood pressure at trough of losartan 50mg /
hydroclorothiazide 12. 5mg group) - (Reduction from baseline in sitting diastolic blood
pressure at trough of telmisartan 40mg / hydrochlorothiazide 12. 5mg group) > 3 mmHg HA:
(Reduction from baseline in sitting diastolic blood pressure at trough of losartan 50mg /
hydroclorothiazide 12. 5mg group) - (Reduction from baseline in sitting diastolic blood
pressure at trough of telmisartan 40mg / hydrochlorothiazide 12. 5mg group) ? 3 mmHg
Comparison(s):
Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours
post-dosing) at the last observation during the double-blind phase.
A 24-hour post-dose timepoint at the last visit of the run-in phase will be specified as the
baseline trough measurement.
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Locations and Contacts
Machay Memorial Hospital, Taipei 104, Taiwan
Additional Information
Starting date: March 2004
Ending date: January 2005
Last updated: January 12, 2007
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