Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01286558
First received: January 28, 2011
Last updated: June 17, 2014
Last verified: January 2014
  Purpose

Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.

In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients.

Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.


Condition Intervention Phase
Hypertension
Drug: 40 mg telmisartan
Drug: 5 mg amlodipine
Drug: 80 mg 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 80mg Plus Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination in Patients With Hypertension

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: Reference baseline, 8 weeks ] [ Designated as safety issue: No ]
    Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, 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: Reference baseline, 8 weeks ] [ Designated as safety issue: No ]
    Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

  • Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP [ Time Frame: Reference baseline, 8 weeks ] [ Designated as safety issue: No ]
    Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined

  • Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP [ Time Frame: Reference baseline, 8 weeks ] [ Designated as safety issue: No ]
    Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined

  • Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP [ Time Frame: Pseudo-baseline, 14 weeks ] [ Designated as safety issue: No ]
    Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined

  • Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP [ Time Frame: Pseudo-baseline, 14 weeks ] [ Designated as safety issue: No ]
    Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined

  • Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM [ Time Frame: Reference baseline, 8 weeks ] [ Designated as safety issue: No ]
    Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined

  • Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM [ Time Frame: Reference baseline, 8 weeks ] [ Designated as safety issue: No ]
    Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined

  • 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 DBP 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: 225
Study Start Date: January 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 80mg telmisartan and 5mg amlodipine FDC
once daily
Drug: 5 mg amlodipine
once daily
Drug: 80 mg telmisartan
once daily
Active Comparator: 40mg telmisartan and 5mg amlodipine FDC
once daily
Drug: 40 mg telmisartan
once daily
Drug: 5 mg amlodipine
once daily

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion criteria:

  1. 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
  2. Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.

Exclusion criteria:

  1. Patients taking 3 or more antihypertensive drugs at signing the informed consent form
  2. Patients with known or suspected secondary hypertension
  3. Patients with clinically relevant cardiac arrhythmia
  4. Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
  5. Patients with recent cardiovascular events
  6. Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
  7. 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
  8. 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
  9. Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
  10. Patients with hepatic and/or renal dysfunction
  11. 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: NCT01286558

Locations
Japan
1235.37.01 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1235.37.07 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima, Japan
1235.37.08 Boehringer Ingelheim Investigational Site
Itoshima, Fukuoka, Japan
1235.37.02 Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo, Japan
1235.37.05 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.37.03 Boehringer Ingelheim Investigational Site
Ota-ku, Tokyo, Japan
1235.37.06 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
1235.37.04 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, 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: NCT01286558     History of Changes
Other Study ID Numbers: 1235.37
Study First Received: January 28, 2011
Results First Received: September 20, 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 28, 2014