Overview

This trial is active, not recruiting.

Condition hypertension
Treatments placebo, telmisartan + hctz, amlodipine
Phase phase 3
Sponsor Boehringer Ingelheim
Start date July 2013
End date January 2014
Trial size 130 participants
Trial identifier NCT01911780, 1348.2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment
Arm
(Experimental)
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
FDC tablet
amlodipine
capsule
(Active Comparator)
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)
placebo
placebo matching amlodipine capsule
telmisartan + hctz
FDC tablet

Primary Outcomes

Measure
Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period
time frame: baseline and week 8

Secondary Outcomes

Measure
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
time frame: week 8
The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52weeks of the extension period
time frame: week 52
Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period
time frame: baseline and week 8
Change from baseline in mean seated DBP at trough after 52weeks of the extension period
time frame: baseline and week 52
Change from baseline in mean seated SBP at trough after 52weeks of the extension period
time frame: baseline and week 52

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.