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

Last updated: February 26, 2016
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Stress

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT01911780
1348.2
  • Ages 20-100
  • All Genders

Study 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 amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.

Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg.

In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period.

In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugsand mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and meanseated systolic blood pressure (SBP) must be =<200 mmHg

  2. Able to stop all current antihypertensive drugs (other than study medication) fromVisit 1b through the end of the trial without risk to the patient based on theinvestigator's opinion

  3. Age 20 years or older

Exclusion

Exclusion criteria:

  1. Patients with known or suspected secondary hypertension

  2. Patients with clinically relevant cardiac arrhythmia

  3. Congestive heart failure with New York Heart Association (NYHA) functional classIII-IV

  4. Patients with recent cardiovascular events

  5. Patients with recent stroke events

  6. Patients with a history of sudden deterioration of renal function with angiotensin IIreceptor blockers or angiotensin converting enzyme inhibitors; or patients withpost-renal transplant or post-nephrectomy

  7. Patients with hepatic and/or renal dysfunction

  8. Pre-menopausal women who are nursing or pregnant

Study Design

Total Participants: 132
Study Start date:
July 01, 2013
Estimated Completion Date:
January 31, 2015

Connect with a study center

  • 1348.2.020 Boehringer Ingelheim Investigational Site

    Chiyoda-ku, Tokyo,
    Japan

    Site Not Available

  • 1348.2.008 Boehringer Ingelheim Investigational Site

    Chuo-ku, Fukuoka, Fukuoka,
    Japan

    Site Not Available

  • 1348.2.018 Boehringer Ingelheim Investigational Site

    Chuo-ku,Kobe, Hyogo,
    Japan

    Site Not Available

  • 1348.2.006 Boehringer Ingelheim Investigational Site

    Chuo-ku,Tokyo,
    Japan

    Site Not Available

  • 1348.2.013 Boehringer Ingelheim Investigational Site

    Chuo-ku,Tokyo,
    Japan

    Site Not Available

  • 1348.2.021 Boehringer Ingelheim Investigational Site

    Chuo-ku,Tokyo,
    Japan

    Site Not Available

  • 1348.2.012 Boehringer Ingelheim Investigational Site

    Hirakata, Osaka,
    Japan

    Site Not Available

  • 1348.2.011 Boehringer Ingelheim Investigational Site

    Kasaoka, Okayama,
    Japan

    Site Not Available

  • 1348.2.001 Boehringer Ingelheim Investigational Site

    Kawasaki, Kanagawa,
    Japan

    Site Not Available

  • 1348.2.019 Boehringer Ingelheim Investigational Site

    Kita-ku, Osaka-shi, Osaka,
    Japan

    Site Not Available

  • 1348.2.014 Boehringer Ingelheim Investigational Site

    Kiyota-ku, Sapporo-shi, Hokkaido,
    Japan

    Site Not Available

  • 1348.2.002 Boehringer Ingelheim Investigational Site

    Kumamoto, Kumamoto,
    Japan

    Site Not Available

  • 1348.2.007 Boehringer Ingelheim Investigational Site

    Nakano-ku,Tokyo,
    Japan

    Site Not Available

  • 1348.2.009 Boehringer Ingelheim Investigational Site

    Nishi-ku, Fukuoka, Fukuoka,
    Japan

    Site Not Available

  • 1348.2.005 Boehringer Ingelheim Investigational Site

    Takatsuki, Osaka,
    Japan

    Site Not Available

  • 1348.2.016 Boehringer Ingelheim Investigational Site

    Uji, Kyoto,
    Japan

    Site Not Available

  • 1348.2.010 Boehringer Ingelheim Investigational Site

    Yoshikawa, Saitama,
    Japan

    Site Not Available

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