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Status:

COMPLETED

Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Hypertension

Eligibility:

All Genders

20-100 years

Phase:

PHASE3

Brief Summary

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be \>=90 and \<=114 mmHg and mean seated systolic blood pressure (SBP) must be =\<200 mmHg
  • Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
  • Age 20 years or older
  • Exclusion criteria:
  • 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 recent stroke events
  • Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
  • Patients with hepatic and/or renal dysfunction
  • Pre-menopausal women who are nursing or pregnant

Exclusion

    Key Trial Info

    Start Date :

    July 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2015

    Estimated Enrollment :

    132 Patients enrolled

    Trial Details

    Trial ID

    NCT01911780

    Start Date

    July 1 2013

    End Date

    January 1 2015

    Last Update

    March 28 2016

    Active Locations (17)

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

    Page 1 of 5 (17 locations)

    1

    1348.2.020 Boehringer Ingelheim Investigational Site

    Chiyoda-ku, Tokyo, Japan

    2

    1348.2.008 Boehringer Ingelheim Investigational Site

    Chuo-ku, Fukuoka, Fukuoka, Japan

    3

    1348.2.018 Boehringer Ingelheim Investigational Site

    Chuo-ku,Kobe, Hyogo, Japan

    4

    1348.2.006 Boehringer Ingelheim Investigational Site

    Chuo-ku,Tokyo, Japan