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Combination of Telmisartan 40 mg Plus Hydrochlorothiazide (HCTZ) 12.5 mg vs. Telmisartan 40 mg Alone in Patients With Essential Hypertension Who Fail to Respond Adequately to Telmisartan Monotherapy

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ClinicalTrials.gov Identifier: NCT00144222
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : November 5, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:
The objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) 40 mg in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan 40 mg/HCTZ 12.5 mg Drug: Telmisartan 40 mg Phase 3

Detailed Description:

This is a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel-group study in patients with essential hypertension who fail to respond adequately to telmisartan (Micardis) 40 mg monotherapy.

After a screening and a 2-week washout period (screening period), the patients will enter 4-week open-label run-in period with telmisartan (Micardis) 40 mg monotherapy to assess eligibility. The study will be terminated for those who have responded to telmisartan (Micardis) 40 mg monotherapy at the end of 4-week open-label run-in period with telmisartan (Micardis) 40 mg monotherapy (mean seated DBP < 90 mmHg). About 200 patients not responding adequately to telmisartan (Micardis) 40 mg monotherapy will be randomised and treated for 8 weeks with once-daily administration of either telmisartan (Micardis) 40 mg or a fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg (double-blind treatment period).

Study Hypothesis:

The hypothesis is that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis) 40 mg in pat ient with essential hypertension who fail to respond adequately to telmisartan monotherapy.

Comparison(s):

For the primary comparison the change from baseline in mean stated trough DBP at the end of the 8-week double-blind treatment will be expressed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 40 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 40 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 40 mg
Study Start Date : January 2005
Actual Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in mean seated trough DBP after eight weeks of the double-blind treatment period [ Time Frame: after 8 weeks ]

Secondary Outcome Measures :
  1. Change in seated trough SBP [ Time Frame: after 8 weeks ]
  2. Seated DBP control rate (seated trough DBP < 90 mmHg) [ Time Frame: after 8 weeks ]
  3. Seated DBP response rate V2 (seated trough DBP < 90 mmHg and/or reduction from pseudo-baseline in seated trough DBP ≥ 10 mmHg) [ Time Frame: after 8 weeks ]
  4. Seated DBP response rate V3 (seated trough DBP < 90 mmHg and/or reduction from pseudo-baseline in seated trough DBP ≥ 10 mmHg) [ Time Frame: after 8 weeks ]
  5. Seated SBP response rate V2 (seated trough SBP < 140 mmHg and/or reduction from pseudo-baseline in seated trough SBP ≥ 10 mmHg) [ Time Frame: after 8 weeks ]
  6. Seated SBP response rate V3 (seated trough SBP ≥ 140 mmHg at baseline and seated trough SBP < 140 mmHg and/or reduction from baseline in seated trough SBP ≥ 10 mmHg) [ Time Frame: after 8 weeks ]
  7. Change in trough pulse pressure [ Time Frame: after 8 weeks ]
  8. Plasma concentrations of Telmisartan and HCTZ [ Time Frame: Day 56 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Essential hypertensive patients who meet all the criteria as follows:

    • Mean seated DBP must be >= 95 and <= 114 mmHg at Visit 2
    • Mean seated SBP must be >= 140 and <= 200 mmHg at Visit 2
    • Mean seated DBP must be >= 90 and <= 114 mmHg at Visit 3
    • Mean seated SBP must be <= 200 mmHg at Visit 3

Exclusion Criteria:

  • Patients taking 4 or more anti-hypertensive medications at Visit 1
  • Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144222


Locations
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Japan
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 060-0003
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan, 163-6003
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Study Coordinator Nippon Boehringer Ingelheim Co., Ltd.
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00144222    
Other Study ID Numbers: 502.436
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action