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

Hypertension Clinical Trial

Official title:

An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg, Followed by a 52 Weeks Extension Study to Assess Long Term Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911780
• Other study ID #: 1348.2
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2013
• Last updated: February 4, 2015
• Start date: July 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion criteria:

1. Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean seated systolic blood pressure (SBP) must be =<200 mmHg

2. Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion

3. Age 20 years or older

Exclusion criteria:

1. Patients with known or suspected secondary hypertension

2. Patients with clinically relevant cardiac arrhythmia

3. Congestive heart failure with New York Heart Association (NYHA) functional class III-IV

4. Patients with recent cardiovascular events

5. Patients with recent stroke events

6. Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy

7. Patients with hepatic and/or renal dysfunction

8. Pre-menopausal women who are nursing or pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• placebo
placebo matching amlodipine capsule
• telmisartan + HCTZ
FDC tablet
• telmisartan + HCTZ
FDC tablet
• amlodipine
capsule

Locations

Country	Name	City	State
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	1348.2.021 Boehringer Ingelheim Investigational Site	Chuo-ku,Tokyo
Japan	1348.2.012 Boehringer Ingelheim Investigational Site	Hirakata, Osaka
Japan	1348.2.011 Boehringer Ingelheim Investigational Site	Kasaoka, Okayama
Japan	1348.2.001 Boehringer Ingelheim Investigational Site	Kawasaki, Kanagawa
Japan	1348.2.019 Boehringer Ingelheim Investigational Site	Kita-ku, Osaka-shi, Osaka
Japan	1348.2.014 Boehringer Ingelheim Investigational Site	Kiyota-ku, Sapporo-shi, Hokkaido
Japan	1348.2.002 Boehringer Ingelheim Investigational Site	Kumamoto, Kumamoto
Japan	1348.2.007 Boehringer Ingelheim Investigational Site	Nakano-ku,Tokyo
Japan	1348.2.009 Boehringer Ingelheim Investigational Site	Nishi-ku, Fukuoka, Fukuoka
Japan	1348.2.005 Boehringer Ingelheim Investigational Site	Takatsuki, Osaka
Japan	1348.2.016 Boehringer Ingelheim Investigational Site	Uji, Kyoto
Japan	1348.2.010 Boehringer Ingelheim Investigational Site	Yoshikawa, Saitama

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period		baseline and week 8	No
Secondary	The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period		week 8	No
Secondary	The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52weeks of the extension period		week 52	No
Secondary	Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period		baseline and week 8	No
Secondary	Change from baseline in mean seated DBP at trough after 52weeks of the extension period		baseline and week 52	No
Secondary	Change from baseline in mean seated SBP at trough after 52weeks of the extension period		baseline and week 52	No