Phase 3 Completed N=225 Randomized Double-blind Treatment

Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)

Hypertension

Source: ClinicalTrials.gov NCT01286558 ↗

Enrolled (actual)

225

Serious AEs

0.9%

Results posted

Oct 2012

Primary outcomePrimary: Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough — 4.93; 3.47 mm Hg

Summary

Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended. In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients. Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough	4.93; 3.47	—
SECONDARY Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough	5.55; 3.41	—
SECONDARY Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP	-1.54; -0.33	—
SECONDARY Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP	-2.81; -0.91	—
SECONDARY Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP	-12.16; -11.28	—
SECONDARY Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP	-20.96; -19.32	—
SECONDARY Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM	-1.04; -0.22; -1.95; 0.32; -2.25; 2.87	—
SECONDARY Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM	-6.54; -1.78; -2.78; -0.28; -3.41; 2.72	—
SECONDARY Seated DBP Control Rate at Trough	53.1; 60.0; 46.9; 40.0	—
SECONDARY Seated SBP Control Rate at Trough	55.2; 55.3; 44.8; 44.7	—
SECONDARY Seated DBP Response Rate at Trough	29.5; 32.1; 70.5; 67.9	—
SECONDARY Seated SBP Response Rate at Trough	19.6; 17.9; 80.4; 82.1	—
SECONDARY Seated Blood Pressure (BP) Normalisation at Trough	41; 44; 21; 13; 23; 26	—

Eligibility Criteria

Inclusion criteria

Essential hypertensive patients
If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be >=90 and >=114 mmHg
If not taking any antihypertensive drugs, mean seated DBP must be >=95 and >=114 mmHg
Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.

Exclusion criteria

Patients taking 3 or more antihypertensive drugs at signing the informed consent form
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 a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy
Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors
Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
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 (NCT01286558). 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.