Clinical trial NCT01222520: Telmisartan 80mg Non-responder Trial
Official title: An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg+ Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 80 mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly.

In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg, the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg.

Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.


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

Primary outcomes:
measure: Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough
timeFrame: Baseline, 8 weeks
measure: Seated DBP Control Rate at Trough
timeFrame: 8 weeks
measure: Seated SBP Control Rate at Trough
timeFrame: 8 weeks
measure: Seated DBP Response Rate at Trough
timeFrame: 8 weeks
measure: Seated SBP Response Rate at Trough
timeFrame: 8 weeks
measure: Seated Blood Pressure (BP) Normalisation at Trough
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chuo-ku,Tokyo
country: Japan
facility: 1235.36.01 Boehringer Ingelheim Investigational Site
city: Hiroshima, Hiroshima
country: Japan
facility: 1235.36.04 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1235.36.02 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1235.36.03 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: