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

NCT ID: NCT01911780

Last Updated: 2016-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-01-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

telmisartan + HCTZ + 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)

Group Type: EXPERIMENTAL

telmisartan + HCTZ

Intervention Type: DRUG

FDC tablet

amlodipine

Intervention Type: DRUG

capsule

telmisartan + HCTZ + 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)

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: DRUG

placebo matching amlodipine capsule

telmisartan + HCTZ

Intervention Type: DRUG

FDC tablet

Interventions

placebo

placebo matching amlodipine capsule

Intervention Type: DRUG

telmisartan + HCTZ

FDC tablet

Intervention Type: DRUG

telmisartan + HCTZ

FDC tablet

Intervention Type: DRUG

amlodipine

capsule

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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, , Japan

Countries

Japan

Other Identifiers

1348.2

Identifier Type: -

Identifier Source: org_study_id