Filtered Trial for Amlodipine Non-responder

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: amlodipine; Drug: telmisartan+amlodipine

• Study Type: Interventional
• Enrollment (Actual): 531
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Azumino, Nagano, Japan
    • 1235.13.037 Boehringer Ingelheim Investigational Site
  • Higashiosaka, Osaka, Japan
    • 1235.13.023 Boehringer Ingelheim Investigational Site
  • Itabashi-ku, Tokyo, Japan
    • 1235.13.021 Boehringer Ingelheim Investigational Site
  • Kashihara, Osaka, Japan
    • 1235.13.014 Boehringer Ingelheim Investigational Site
  • Kitaazumi-gun, Nagano, Japan
    • 1235.13.038 Boehringer Ingelheim Investigational Site
  • Kiyose, Tokyo, Japan
    • 1235.13.009 Boehringer Ingelheim Investigational Site
  • Kobe, Hyogo, Japan
    • 1235.13.041 Boehringer Ingelheim Investigational Site
  • Komoro, Nagano, Japan
    • 1235.13.035 Boehringer Ingelheim Investigational Site
  • Koriyama, Fukushima, 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
  • Koshigaya, Saitama,, Japan
    • 1235.13.007 Boehringer Ingelheim Investigational Site
  • Koto-ku, Tokyo, Japan
    • 1235.13.008 Boehringer Ingelheim Investigational Site
  • Matsudo, Chiba, Japan
    • 1235.13.005 Boehringer Ingelheim Investigational Site
  • Mito, Ibaraki, Japan
    • 1235.13.026 Boehringer Ingelheim Investigational Site
  • Nagoya, Aichi, Japan
    • 1235.13.013 Boehringer Ingelheim Investigational Site
  • Okayama, Okayama,, Japan
    • 1235.13.016 Boehringer Ingelheim Investigational Site
  • Osaka, Osaka, Japan
    • 1235.13.040 Boehringer Ingelheim Investigational Site
  • Saitama, Saitama, Japan
    • 1235.13.025 Boehringer Ingelheim Investigational Site
  • Sapporo, Hokkaido, 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
  • Sendai, Miyagi, 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
  • Shimoina-gun, Nagano, Japan
    • 1235.13.036 Boehringer Ingelheim Investigational Site
  • Shinjuku-ku, Tokyo, Japan
    • 1235.13.042 Boehringer Ingelheim Investigational Site
  • Shinjyuku-ku, Tokyo, Japan
    • 1235.13.010 Boehringer Ingelheim Investigational Site
  • Shinjyuku-ku,Tokyo, Japan
    • 1235.13.011 Boehringer Ingelheim Investigational Site
  • Shizuoka, Shizuoka, Japan
    • 1235.13.022 Boehringer Ingelheim Investigational Site
  • Suita, Osaka,, Japan
    • 1235.13.015 Boehringer Ingelheim Investigational Site
  • Takamatsu, Kagawa, 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
  • Takaoka, Toyama, Japan
    • 1235.13.012 Boehringer Ingelheim Investigational Site
  • Takaoka,Toyama, Japan
    • 1235.13.039 Boehringer Ingelheim Investigational Site
  • Tsuchiura, Ibaraki, Japan
    • 1235.13.020 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: October 29, 2007
• First Submitted That Met QC Criteria: November 12, 2007
• First Posted (Estimate): November 14, 2007

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Telmisartan; Telmisartan amlodipine combination
• Other Study ID Numbers: 1235.13