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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
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00133185
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: telmisartan 40mg / hydrochlorothiazide 12.5mg
Drug: osartan 50mg / hydrochlorothiazide 12.5mg
Phase III

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Telmisartan Losartan Losartan potassium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Estimated Enrollment: 40
Study Start Date: March 2004
Estimated Study Completion Date: January 2005
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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133185

Locations
Taiwan
Machay Memorial Hospital
Taipei, Taiwan, 104
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Taiwan Ltd.
  More Information

Study ID Numbers: 502.406
Study First Received: August 22, 2005
Last Updated: January 12, 2007
ClinicalTrials.gov Identifier: NCT00133185  
Health Authority: Taiwan, Republic of China: Dept. of Health, Executive Yuan, Taiwan

Study placed in the following topic categories:
Losartan
Clotrimazole
Benzoates
Miconazole
Tioconazole
Vascular Diseases
Telmisartan
Angiotensin II
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Natriuretic Agents
Antifungal Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009