Clinical trial NCT00550953: Filtered Trial for Telmisartan 40mg Non-responder
Official title: Filtered Trial for Telmisartan 40mg Non-responder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 314
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks
timeFrame: Baseline and 8 Weeks
Secondary outcomes:
measure: Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)
timeFrame: 8 weeks
measure: Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)
timeFrame: 8 weeks
measure: Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
timeFrame: 8 weeks
measure: Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
timeFrame: 8 weeks
measure: Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)
timeFrame: 8 weeks
measure: Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
timeFrame: First administration of randomised treatment to 24 hours post last dose of randomised treatment
Other outcomes:
Locations:
city: Chofu, Tokyo
country: Japan
facility: 1235.14.002 Boehringer Ingelheim Investigational Site
city: Musashino, Tokyo
country: Japan
facility: 1235.14.003 Boehringer Ingelheim Investigational Site
city: Nishi-ku, Hiroshima, Hiroshima
country: Japan
facility: 1235.14.005 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1235.14.004 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1235.14.001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: