Telmisartan 80mg Non-responder Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01222520
First received: October 15, 2010
Last updated: June 17, 2014
Last verified: January 2014
  Purpose

If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly.

In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg, the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg.

Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.


Condition Intervention Phase
Hypertension
Drug: Telmisartan and amlodipine
Drug: Telmisartan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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+ Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 80 mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg Monotherapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing


Secondary Outcome Measures:
  • Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

  • Seated DBP Control Rate at Trough [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing

  • Seated SBP Control Rate at Trough [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    SBP control rate: The rate of patients with controlled seated SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing

  • Seated DBP Response Rate at Trough [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline ≥10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing

  • Seated SBP Response Rate at Trough [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline ≥20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing

  • Seated Blood Pressure (BP) Normalisation at Trough [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing


Enrollment: 174
Study Start Date: October 2010
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telmisartan and amlodipine FDC
once a daily
Drug: Telmisartan and amlodipine
Telmisartan 80 mg and amlodipine 5 mg once a daily
Active Comparator: Telmisartan monotherapy
once a daily
Drug: Telmisartan
80 mg once a daily

  Eligibility

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

Inclusion criteria:

  • Essential hypertensive patients

    • If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be >=90 and >=114 mmHg
    • If not taking any antihypertensive drugs, mean seated DBP must be >=95 and >=114 mmHg
  • Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.

Exclusion criteria:

  • Patients taking 3 or more antihypertensive drugs at signing the informed consent form
  • 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 a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
  • Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy
  • Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors
  • Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
  • Patients with hepatic and/or renal dysfunction
  • 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: NCT01222520

Locations
Japan
1235.36.01 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1235.36.04 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima, Japan
1235.36.02 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1235.36.03 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01222520     History of Changes
Other Study ID Numbers: 1235.36
Study First Received: October 15, 2010
Results First Received: May 31, 2012
Last Updated: June 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 21, 2014