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: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: placebo
Drug: telmisartan + HCTZ
Drug: amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 130
Study Start Date: July 2013
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: telmisartan + HCTZ
FDC tablet
Drug: amlodipine
capsule
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)
Drug: placebo
placebo matching amlodipine capsule
Drug: telmisartan + HCTZ
FDC tablet

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911780

Locations
Japan
1348.2.020 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1348.2.008 Boehringer Ingelheim Investigational Site
Chuo-ku, Fukuoka, Fukuoka, Japan
1348.2.018 Boehringer Ingelheim Investigational Site
Chuo-ku,Kobe, Hyogo, Japan
1348.2.013 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.2.021 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.2.006 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.2.012 Boehringer Ingelheim Investigational Site
Hirakata, Osaka, Japan
1348.2.011 Boehringer Ingelheim Investigational Site
Kasaoka, Okayama, Japan
1348.2.001 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan
1348.2.019 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka-shi, Osaka, Japan
1348.2.014 Boehringer Ingelheim Investigational Site
Kiyota-ku, Sapporo-shi, Hokkaido, Japan
1348.2.002 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto, Japan
1348.2.007 Boehringer Ingelheim Investigational Site
Nakano-ku,Tokyo, Japan
1348.2.009 Boehringer Ingelheim Investigational Site
Nishi-ku, Fukuoka, Fukuoka, Japan
1348.2.005 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka, Japan
1348.2.016 Boehringer Ingelheim Investigational Site
Uji, Kyoto, Japan
1348.2.010 Boehringer Ingelheim Investigational Site
Yoshikawa, Saitama, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01911780     History of Changes
Other Study ID Numbers: 1348.2
Study First Received: July 26, 2013
Last Updated: July 9, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Amlodipine
Telmisartan
Benzoates
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 10, 2014