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

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

Tracking Information

• First Submitted Date: September 2, 2005
• First Posted Date: September 5, 2005
• Last Update Posted Date: November 5, 2013
• Study Start Date: January 2005
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 4, 2013): Change in mean seated trough DBP after eight weeks of the double-blind treatment period [ Time Frame: after 8 weeks ]
• Original Primary Outcome Measures (submitted: September 2, 2005): Primary Endpoint: The primary endpoint is the change from baseline in mean stated trough DBT

Current Secondary Outcome Measures (submitted: November 4, 2013)

• Change in seated trough SBP [ Time Frame: after 8 weeks ]
• Seated DBP control rate (seated trough DBP < 90 mmHg) [ Time Frame: after 8 weeks ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• Change in trough pulse pressure [ Time Frame: after 8 weeks ]
• Plasma concentrations of Telmisartan and HCTZ [ Time Frame: Day 56 ]

• Original Secondary Outcome Measures (submitted: September 2, 2005): -Change from baseline in seated trough SBP at the end of 8-week double-blind treatment -Seated DBP control rate (seated trough DBP < 90 mmHg at the end of 8-week double-blind treatment)
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• 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.

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 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/HCTZ 12.5 mg
• Drug: Telmisartan 40 mg

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 4, 2013): 218
• Original Enrollment (submitted: September 2, 2005): 200
• Study Completion Date: August 2005
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

Eligibility 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.)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00144222
• Other Study ID Numbers: 502.436
• 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; Nippon Boehringer Ingelheim Co., Ltd.

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