Filtered Trial for Amlodipine Non-responder

NCT00558064 | Completed Phase 3 Results

• 1 other identifier: 1235.13
• Study Type: interventional
• Target: 531
• Locations: 1 country
• Sites: 41

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)

  Baseline and 8 Weeks

• Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)

  8 weeks

• Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)

  8 weeks

• Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)

  8 weeks

• Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks

  8 weeks

Interventions

telmisartan+amlodipine DRUG

amlodipine DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Essential hypertensive patients satisfying all of the following criteria;
• Male or Female
• Age \> 20 years
• Outpatient
• Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
• 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.

You may not qualify if:

• Taking four or more anti-hypertensive medications
• Secondary hypertension
• 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.
• Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
• Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
• History of myocardial infarction or cardiac surgery within last 6 months
• History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
• History of unstable angina within last 3 months
• Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
• History of stroke or transient ischemic attack within last 6 months
• 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
• Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
• Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
• Hepatic and/or renal dysfunction
• Diagnosed biliary atresia or cholestasis

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (41)

1235.13.037 Boehringer Ingelheim Investigational Site

Azumino, Nagano, Japan

Location

1235.13.023 Boehringer Ingelheim Investigational Site

Higashiosaka, Osaka, Japan

Location

1235.13.021 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, Japan

Location

1235.13.014 Boehringer Ingelheim Investigational Site

Kashihara, Osaka, Japan

Location

1235.13.038 Boehringer Ingelheim Investigational Site

Kitaazumi-gun, Nagano, Japan

Location

1235.13.009 Boehringer Ingelheim Investigational Site

Kiyose, Tokyo, Japan

Location

1235.13.041 Boehringer Ingelheim Investigational Site

Kobe, Hyogo, Japan

Location

1235.13.035 Boehringer Ingelheim Investigational Site

Komoro, Nagano, Japan

Location

1235.13.003 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

1235.13.004 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

1235.13.027 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

1235.13.007 Boehringer Ingelheim Investigational Site

Koshigaya, Saitama,, Japan

Location

1235.13.008 Boehringer Ingelheim Investigational Site

Koto-ku, Tokyo, Japan

Location

1235.13.005 Boehringer Ingelheim Investigational Site

Matsudo, Chiba, Japan

Location

1235.13.026 Boehringer Ingelheim Investigational Site

Mito, Ibaraki, Japan

Location

1235.13.013 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1235.13.016 Boehringer Ingelheim Investigational Site

Okayama, Okayama,, Japan

Location

1235.13.040 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1235.13.025 Boehringer Ingelheim Investigational Site

Saitama, Saitama, Japan

Location

1235.13.001 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1235.13.024 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1235.13.028 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1235.13.030 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1235.13.031 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1235.13.033 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1235.13.034 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1235.13.002 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

1235.13.018 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

1235.13.019 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

1235.13.036 Boehringer Ingelheim Investigational Site

Shimoina-gun, Nagano, Japan

Location

1235.13.042 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

1235.13.010 Boehringer Ingelheim Investigational Site

Shinjyuku-ku, Tokyo, Japan

Location

1235.13.011 Boehringer Ingelheim Investigational Site

Shinjyuku-ku,Tokyo, Japan

Location

1235.13.022 Boehringer Ingelheim Investigational Site

Shizuoka, Shizuoka, Japan

Location

1235.13.015 Boehringer Ingelheim Investigational Site

Suita, Osaka,, Japan

Location

1235.13.017 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, Japan

Location

1235.13.029 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, Japan

Location

1235.13.032 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, Japan

Location

1235.13.012 Boehringer Ingelheim Investigational Site

Takaoka, Toyama, Japan

Location

1235.13.039 Boehringer Ingelheim Investigational Site

Takaoka,Toyama, Japan

Location

1235.13.020 Boehringer Ingelheim Investigational Site

Tsuchiura, Ibaraki, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan amlodipine combination; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: November 14, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Last Updated: July 8, 2014
• Results First Posted: February 1, 2010

Record last verified: 2013-12

Locations

JP (41)