Filtered Trial for Amlodipine Non-responder

Hypertension Clinical Trial

Official title:

Filtered Trial for Amlodipine Non-responder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558064
• Other study ID #: 1235.13
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2007
• Last updated: June 24, 2014
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 531
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• telmisartan+amlodipine

• amlodipine

Locations

Country	Name	City	State
Japan	1235.13.037 Boehringer Ingelheim Investigational Site	Azumino, Nagano
Japan	1235.13.023 Boehringer Ingelheim Investigational Site	Higashiosaka, Osaka
Japan	1235.13.021 Boehringer Ingelheim Investigational Site	Itabashi-ku, Tokyo
Japan	1235.13.014 Boehringer Ingelheim Investigational Site	Kashihara, Osaka
Japan	1235.13.038 Boehringer Ingelheim Investigational Site	Kitaazumi-gun, Nagano
Japan	1235.13.009 Boehringer Ingelheim Investigational Site	Kiyose, Tokyo
Japan	1235.13.041 Boehringer Ingelheim Investigational Site	Kobe, Hyogo
Japan	1235.13.035 Boehringer Ingelheim Investigational Site	Komoro, Nagano
Japan	1235.13.003 Boehringer Ingelheim Investigational Site	Koriyama, Fukushima
Japan	1235.13.004 Boehringer Ingelheim Investigational Site	Koriyama, Fukushima
Japan	1235.13.027 Boehringer Ingelheim Investigational Site	Koriyama, Fukushima
Japan	1235.13.007 Boehringer Ingelheim Investigational Site	Koshigaya, Saitama,
Japan	1235.13.008 Boehringer Ingelheim Investigational Site	Koto-ku, Tokyo
Japan	1235.13.005 Boehringer Ingelheim Investigational Site	Matsudo, Chiba
Japan	1235.13.026 Boehringer Ingelheim Investigational Site	Mito, Ibaraki
Japan	1235.13.013 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1235.13.016 Boehringer Ingelheim Investigational Site	Okayama, Okayama,
Japan	1235.13.040 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1235.13.025 Boehringer Ingelheim Investigational Site	Saitama, Saitama
Japan	1235.13.001 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1235.13.024 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1235.13.028 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1235.13.030 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1235.13.031 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1235.13.033 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1235.13.034 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1235.13.002 Boehringer Ingelheim Investigational Site	Sendai, Miyagi
Japan	1235.13.018 Boehringer Ingelheim Investigational Site	Sendai, Miyagi
Japan	1235.13.019 Boehringer Ingelheim Investigational Site	Sendai, Miyagi
Japan	1235.13.036 Boehringer Ingelheim Investigational Site	Shimoina-gun, Nagano
Japan	1235.13.042 Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo
Japan	1235.13.010 Boehringer Ingelheim Investigational Site	Shinjyuku-ku, Tokyo
Japan	1235.13.011 Boehringer Ingelheim Investigational Site	Shinjyuku-ku,Tokyo
Japan	1235.13.022 Boehringer Ingelheim Investigational Site	Shizuoka, Shizuoka
Japan	1235.13.015 Boehringer Ingelheim Investigational Site	Suita, Osaka,
Japan	1235.13.017 Boehringer Ingelheim Investigational Site	Takamatsu, Kagawa
Japan	1235.13.029 Boehringer Ingelheim Investigational Site	Takamatsu, Kagawa
Japan	1235.13.032 Boehringer Ingelheim Investigational Site	Takamatsu, Kagawa
Japan	1235.13.012 Boehringer Ingelheim Investigational Site	Takaoka, Toyama
Japan	1235.13.039 Boehringer Ingelheim Investigational Site	Takaoka,Toyama
Japan	1235.13.020 Boehringer Ingelheim Investigational Site	Tsuchiura, Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)	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	Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)	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	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; No: SBP >= 140 mmHg and DPB >= 90 mmHg	8 weeks	No
Secondary	Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG	Clinical relevant abnormalities for blood chemistry, 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

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