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NCT Number: NCT01911780

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1348.2.020 Boehringer Ingelheim Investigational Site, Chiyoda-ku, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

placebo matching amlodipine capsule

telmisartan + HCTZ

Drug

FDC tablet

Amlodipine

Drug

capsule

Primary outcomes

  1. Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.

    Time frame: baseline and 8 weeks

    Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.

Secondary outcomes

  1. Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.

    Time frame: baseline and 8 weeks

    Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.

  2. The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.

    Time frame: Double-blind and 8 weeks

    The percentage of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.

  3. The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.

    Time frame: Reference baseline (week 0) and week 60 (end of extension period)

    The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.

    The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.

  4. Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.

    Time frame: Reference baseline (week 0) and week 60 (end of extension period)

    Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.

    The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.

  5. Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.

    Time frame: Reference baseline (week 0) and week 60 (end of extension period)

    Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.

    The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg, Followed by a 52 Weeks Extension Study to Assess Long Term Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2013
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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