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

Phase 3CompletedNCT01911780

Boehringer Ingelheim132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Hypertension

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (17)

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

...and 7 more locations

Outcomes

Primary Outcomes

Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.

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'.

Time frame: baseline and 8 weeks

Secondary Outcomes

Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.

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'.

Time frame: baseline and 8 weeks

The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.

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'.

Time frame: Double-blind and 8 weeks

The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks 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'.

Time frame: Reference baseline (week 0) and week 60 (end of extension period)

Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the 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'.

Time frame: Reference baseline (week 0) and week 60 (end of extension period)

Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the 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'.

Time frame: Reference baseline (week 0) and week 60 (end of extension period)