Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: placebo; Drug: telmisartan + HCTZ; Drug: amlodipine

• Registration Number: NCT01911780
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.

Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg.

In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period.

In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-30
• Disposition First Submitted: 2014-06-25
• Disposition First Submitted QC: 2014-06-25
• Disposition First Posted: 2014-06-26
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-01-22
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-26
• Last Update Submitted: 2016-02-26
• Results First Posted: 2016-03-28
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telmisartan + HCTZ + placebo	telmisartan + HCTZ	telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
telmisartan + HCTZ + amlodipine	telmisartan + HCTZ	telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
telmisartan + HCTZ + placebo	placebo	telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
telmisartan + HCTZ + amlodipine	amlodipine	telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.	baseline and 8 weeks	Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.

Secondary Outcome Measures

Name	Time	Method
The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.	Reference baseline (week 0) and week 60 (end of extension period)	The number of patients with DBP\<90 mmHg and SBP\<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.; The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.	Double-blind and 8 weeks	The percentage of patients with DBP\<90 mmHg and SBP\<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.	baseline and 8 weeks	Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.	Reference baseline (week 0) and week 60 (end of extension period)	Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.; The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.	Reference baseline (week 0) and week 60 (end of extension period)	Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.; The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.

Trial Locations

Locations (17)

1348.2.021 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku,Tokyo, Japan

1348.2.019 Boehringer Ingelheim Investigational Site; 🇯🇵 Kita-ku, Osaka-shi, Osaka, Japan

1348.2.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Kawasaki, Kanagawa, Japan

1348.2.014 Boehringer Ingelheim Investigational Site; 🇯🇵 Kiyota-ku, Sapporo-shi, Hokkaido, Japan

1348.2.007 Boehringer Ingelheim Investigational Site; 🇯🇵 Nakano-ku,Tokyo, Japan

1348.2.005 Boehringer Ingelheim Investigational Site; 🇯🇵 Takatsuki, Osaka, Japan

1348.2.010 Boehringer Ingelheim Investigational Site; 🇯🇵 Yoshikawa, Saitama, Japan

1348.2.020 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiyoda-ku, Tokyo, Japan

1348.2.008 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Fukuoka, Fukuoka, Japan

1348.2.018 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku,Kobe, Hyogo, Japan

1348.2.006 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku,Tokyo, Japan

1348.2.013 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku,Tokyo, Japan

1348.2.009 Boehringer Ingelheim Investigational Site; 🇯🇵 Nishi-ku, Fukuoka, Fukuoka, Japan

1348.2.012 Boehringer Ingelheim Investigational Site; 🇯🇵 Hirakata, Osaka, Japan

1348.2.011 Boehringer Ingelheim Investigational Site; 🇯🇵 Kasaoka, Okayama, Japan

1348.2.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Kumamoto, Kumamoto, Japan

1348.2.016 Boehringer Ingelheim Investigational Site; 🇯🇵 Uji, Kyoto, Japan