Filtered Trial for Telmisartan 40mg Non-responder

Hypertension Clinical Trial

Official title:

Filtered Trial for Telmisartan 40mg Non-responder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550953
• Other study ID #: 1235.14
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2007
• Last updated: December 12, 2013
• Start date: October 2007

Study information

• Verified date: December 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• telmisartan+amlodipine

• telmisartan

Locations

Country	Name	City	State
Japan	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	1235.14.001 Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 8 Weeks	No
Secondary	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.	Baseline and 8 weeks	No
Secondary	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	8 weeks	No
Secondary	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	8 weeks	No
Secondary	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	8 weeks	No
Secondary	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)	8 weeks	No
Secondary	Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)	Optimal, normal, high normal blood pressure were defined as follows: Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg; Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg; High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg	8 weeks	No
Secondary	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.	First administration of randomised treatment to 24 hours post last dose of randomised treatment	No