Filtered Trial for Telmisartan 40mg Non-responder

Boehringer Ingelheim314 enrolled

Overview

The primary purpose of this study is to: Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

314

Conditions

Hypertension

Interventions

telmisartan+amlodipineDRUG

telmisartanDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Essential hypertensive patients who satisfying non-responder criteria 2. Male or Female 3. Age 20 years or older 4. Outpatient Exclusion Criteria: 1. Taking four or more anti-hypertensive medications 2. Secondary hypertension 3. Mean seated diastolic blood pressure (DBP) \> 114 mmHg and/or mean seated systolic blood pressure (SBP) \> 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP \< 90 mmHg at Visit 3. 4. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias 5. Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV 6. History of myocardial infarction or cardiac surgery within last 6 months 7. History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months 8. History of unstable angina within last 3 months 9. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve 10. History of stroke or transient ischemic attack within last 6 months 11. History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy 12. Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors 13. Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs 14. Hepatic and/or renal dysfunction 15. Diagnosed biliary atresia or cholestasis 16. Hyperkalemia 17. Dehydration 18. Sodium deficiency 19. Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs) 20. Patients who cannot change to the restricted administration and dosage during study period 21. Pre-menopausal women who meet any one of the following 1 - 3: * Pregnant or possibly pregnant (1) * Nursing (2) * Desire to become pregnant during study period (3) 22. Drug or alcohol dependency 23. Complication of malignant tumour or a disease requiring immunosuppressants 24. Compliance of \< 80% or \> 120% during the run-in period 25. Receiving any investigational therapy within 3 months 26. Judged to be inappropriate by the investigator or the sub-investigator

Locations (5)

1235.14.002 Boehringer Ingelheim Investigational Site

Chofu, Tokyo, Japan

1235.14.003 Boehringer Ingelheim Investigational Site

Musashino, Tokyo, Japan

1235.14.005 Boehringer Ingelheim Investigational Site

Nishi-ku, Hiroshima, Hiroshima, Japan

1235.14.004 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Outcomes

Primary Outcomes

Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks

The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

Time frame: Baseline and 8 Weeks

Secondary Outcomes

Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks

The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

Time frame: Baseline and 8 weeks

Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)

Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake

Time frame: 8 weeks

Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)

Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake

Time frame: 8 weeks

Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)

Adequate response defined that seated trough diastolic blood pressure was \<90 mmHg or decreased from reference baseline by \>=10 mmHg at 8 weeks

Time frame: 8 weeks

Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)

Adequate response defined that seated trough systolic blood pressure was \<140 mmHg or decreased from reference baseline by \>=20 mmHg at 8 weeks (0 percent at baseline)

Data from ClinicalTrials.gov

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