NCT01975246

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 Amlodipine 5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Amlodipine 5 mg

Completed Phase 3 Results posted Last updated 6 October 2016

What this trial tests

Phase 3 trial testing Telmisartan + amlodipine in Hypertension in 309 participants. Completed in 1 July 2014.

Timeline

1 November 2013

Primary endpoint
1 June 2014

1 July 2014

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	309
Start date	1 November 2013
Primary completion	1 June 2014
Estimated completion	1 July 2014
Sites	30 locations across Japan

Drugs / interventions tested

• Telmisartan + amlodipine — full drug profile →
• hydrochlorothiazide (hydrochlorothiazide) — full drug profile →
• Telmisartan + amlodipine — full drug profile →
• Placebo

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 20 to 100, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
  Time frame: baseline and week 8
  Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.

Sponsor's own description

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+ amlodipine 5 mg (T80/A5 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+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of hydrochlorothiazide in addition to telmisartan/amlodipine combination for treating hypertensive patients uncontrolled with telmisartan/amlodipine: a randomized, double-blind study.
   Higaki J, Komuro I, Shiki K, Lee G, et al · · 2017 · cited 5× · PMID 27761000 · DOI 10.1038/hr.2016.124