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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01911780
First received: July 26, 2013
Last updated: August 6, 2014
Last verified: August 2014

July 26, 2013
August 6, 2014
July 2013
January 2014   (final data collection date for primary outcome measure)
Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01911780 on ClinicalTrials.gov Archive Site
  • The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52weeks of the extension period [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in mean seated DBP at trough after 52weeks of the extension period [ Time Frame: baseline and week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in mean seated SBP at trough after 52weeks of the extension period [ Time Frame: baseline and week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
  • Drug: placebo
    placebo matching amlodipine capsule
  • Drug: telmisartan + HCTZ
    FDC tablet
  • Drug: amlodipine
    capsule
  • Experimental: telmisartan + HCTZ + amlodipine
    telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
    Interventions:
    • Drug: telmisartan + HCTZ
    • Drug: amlodipine
  • Active Comparator: telmisartan + HCTZ + placebo
    telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
    Interventions:
    • Drug: placebo
    • Drug: telmisartan + HCTZ
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
January 2015
January 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. 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
  2. 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
  3. Age 20 years or older

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 class III-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 II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
  7. Patients with hepatic and/or renal dysfunction
  8. Pre-menopausal women who are nursing or pregnant
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01911780
1348.2
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP