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Status:

COMPLETED

Telmisartan 80mg Non-responder Trial

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Hypertension

Eligibility:

All Genders

20+ years

Phase:

PHASE3

Brief Summary

If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly. In the Japanese 3x3 factorial tria...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Essential hypertensive patients
  • If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be \>=90 and \>=114 mmHg
  • If not taking any antihypertensive drugs, mean seated DBP must be \>=95 and \>=114 mmHg
  • Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.
  • Exclusion criteria:
  • Patients taking 3 or more antihypertensive drugs at signing the informed consent form
  • Patients with known or suspected secondary hypertension
  • Patients with clinically relevant cardiac arrhythmia
  • Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
  • Patients with recent cardiovascular events
  • Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
  • Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy
  • Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors
  • Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
  • Patients with hepatic and/or renal dysfunction
  • Pre-menopausal women who are nursing or pregnant

Exclusion

    Key Trial Info

    Start Date :

    October 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    174 Patients enrolled

    Trial Details

    Trial ID

    NCT01222520

    Start Date

    October 1 2010

    Last Update

    June 27 2014

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    1235.36.01 Boehringer Ingelheim Investigational Site

    Chuo-ku,Tokyo, Japan

    2

    1235.36.04 Boehringer Ingelheim Investigational Site

    Hiroshima, Hiroshima, Japan

    3

    1235.36.02 Boehringer Ingelheim Investigational Site

    Shinjuku-ku, Tokyo, Japan

    4

    1235.36.03 Boehringer Ingelheim Investigational Site

    Suita, Osaka, Japan