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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144222
First received: September 2, 2005
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Hypertension
Drug: Telmisartan 40 mg/HCTZ 12.5 mg
Drug: Telmisartan 40 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in mean seated trough DBP after eight weeks of the double-blind treatment period [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in seated trough SBP [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Seated DBP control rate (seated trough DBP < 90 mmHg) [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in trough pulse pressure [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Plasma concentrations of Telmisartan and HCTZ [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Enrollment: 218
Study Start Date: January 2005
Estimated Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144222

Locations
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
Study Chair: Boehringer Ingelheim Study Coordinator Nippon Boehringer Ingelheim Co., Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00144222     History of Changes
Other Study ID Numbers: 502.436
Study First Received: September 2, 2005
Last Updated: November 4, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on September 29, 2014