Clinical trial NCT00558064: Filtered Trial for Amlodipine Non-responder
Official title: Filtered Trial for Amlodipine Non-responder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 531
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.


Eligibility criteria: Inclusion Criteria:

1. Essential hypertensive patients satisfying all of the following criteria;
2. Male or Female
3. Age \> 20 years
4. Outpatient
5. Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
6. Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.

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: Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)
timeFrame: Baseline and 8 Weeks
Secondary outcomes:
measure: Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)
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
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 Blood Chemistry, 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: Azumino, Nagano
country: Japan
facility: 1235.13.037 Boehringer Ingelheim Investigational Site
city: Higashiosaka, Osaka
country: Japan
facility: 1235.13.023 Boehringer Ingelheim Investigational Site
city: Itabashi-ku, Tokyo
country: Japan
facility: 1235.13.021 Boehringer Ingelheim Investigational Site
city: Kashihara, Osaka
country: Japan
facility: 1235.13.014 Boehringer Ingelheim Investigational Site
city: Kitaazumi-gun, Nagano
country: Japan
facility: 1235.13.038 Boehringer Ingelheim Investigational Site
city: Kiyose, Tokyo
country: Japan
facility: 1235.13.009 Boehringer Ingelheim Investigational Site
city: Kobe, Hyogo
country: Japan
facility: 1235.13.041 Boehringer Ingelheim Investigational Site
city: Komoro, Nagano
country: Japan
facility: 1235.13.035 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 1235.13.003 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 1235.13.004 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 1235.13.027 Boehringer Ingelheim Investigational Site
city: Koshigaya, Saitama,
country: Japan
facility: 1235.13.007 Boehringer Ingelheim Investigational Site
city: Koto-ku, Tokyo
country: Japan
facility: 1235.13.008 Boehringer Ingelheim Investigational Site
city: Matsudo, Chiba
country: Japan
facility: 1235.13.005 Boehringer Ingelheim Investigational Site
city: Mito, Ibaraki
country: Japan
facility: 1235.13.026 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1235.13.013 Boehringer Ingelheim Investigational Site
city: Okayama, Okayama,
country: Japan
facility: 1235.13.016 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1235.13.040 Boehringer Ingelheim Investigational Site
city: Saitama, Saitama
country: Japan
facility: 1235.13.025 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1235.13.001 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1235.13.024 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1235.13.028 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1235.13.030 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1235.13.031 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1235.13.033 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1235.13.034 Boehringer Ingelheim Investigational Site
city: Sendai, Miyagi
country: Japan
facility: 1235.13.002 Boehringer Ingelheim Investigational Site
city: Sendai, Miyagi
country: Japan
facility: 1235.13.018 Boehringer Ingelheim Investigational Site
city: Sendai, Miyagi
country: Japan
facility: 1235.13.019 Boehringer Ingelheim Investigational Site
city: Shimoina-gun, Nagano
country: Japan
facility: 1235.13.036 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1235.13.042 Boehringer Ingelheim Investigational Site
city: Shinjyuku-ku, Tokyo
country: Japan
facility: 1235.13.010 Boehringer Ingelheim Investigational Site
city: Shinjyuku-ku,Tokyo
country: Japan
facility: 1235.13.011 Boehringer Ingelheim Investigational Site
city: Shizuoka, Shizuoka
country: Japan
facility: 1235.13.022 Boehringer Ingelheim Investigational Site
city: Suita, Osaka,
country: Japan
facility: 1235.13.015 Boehringer Ingelheim Investigational Site
city: Takamatsu, Kagawa
country: Japan
facility: 1235.13.017 Boehringer Ingelheim Investigational Site
city: Takamatsu, Kagawa
country: Japan
facility: 1235.13.029 Boehringer Ingelheim Investigational Site
city: Takamatsu, Kagawa
country: Japan
facility: 1235.13.032 Boehringer Ingelheim Investigational Site
city: Takaoka, Toyama
country: Japan
facility: 1235.13.012 Boehringer Ingelheim Investigational Site
city: Takaoka,Toyama
country: Japan
facility: 1235.13.039 Boehringer Ingelheim Investigational Site
city: Tsuchiura, Ibaraki
country: Japan
facility: 1235.13.020 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: