Phase 3 Completed N=309 Randomized Double-blind Treatment

Add-on to Micamlo BP Trial

Hypertension

Source: ClinicalTrials.gov NCT01975246 ↗

Enrolled (actual)

309

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcomePrimary: Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period. — -8.4; -4.5 mmHg — p=<0.0001

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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+ 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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.	-8.4; -4.5	<0.0001 sig
SECONDARY Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.	-12.3; -6.9	<0.0001 sig
SECONDARY The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period	51.7; 36.9	<0.0051 sig

Eligibility Criteria

Inclusion criteria

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
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
Age 20 years or older

Exclusion criteria

Patients with known or suspected secondary hypertension
Patients with clinically relevant cardiac arrhythmia
Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
Patients with recent cardiovascular events
Patients with recent stroke events
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
Patients with hepatic and/or renal dysfunction
Pre-menopausal women who are nursing or pregnant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01975246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.