Trial of Telmisartan 80 mg/HCTZ 12.5 mg and Telmisartan 40 mg/HCTZ 12.5 mg in Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00326768
First received: May 16, 2006
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and telmisartan 40 mg plus HCTZ 12.5 mg in patients with essential hypertension.


Condition Intervention Phase
Hypertension
Drug: Telmisartan 40 mg/HCTZ 12.5 mg
Drug: Telmisartan 40 mg
Drug: Telmisartan 80 mg/HCTZ 12.5 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Long-term (52-week), Safety Trial of the Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 12.5mg and Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg in Patients With Essential Hypertension - Efficacy and Safety Evaluation

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Changes in electrocardiogram (ECG) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Changes in blood pressure and pulse rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seated Diastolic Blood Pressure (DBP) control rate [ Time Frame: after 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Seated Systolic Blood Pressure (SBP) control rate [ Time Frame: after 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Seated DBP response rate [ Time Frame: after 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Seated SBP response rate [ Time Frame: after 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Seated blood pressure (BP) normality criteria [ Time Frame: after 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Changes in seated DBP [ Time Frame: after 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Changes in seated SBP [ Time Frame: after 12 and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 184
Study Start Date: May 2006
Estimated Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

This is a multi-centre study with three centres participating with a target of 30 to 90 patients entering the maintenance period and 20-60 patients completing long-term treatment per centre. The recruitment period will be about three months from the start of the study.

Study Hypothesis:

The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartan/HCTZ fixed-dose combination treatment. This study has no control group; therefore, no hypothesis testing will be performed.

Comparison(s):

This study has no control group.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Essential hypertensive patients who meet the following criteria:

    • In case of using any antihypertensives, mean seated DBP* must be over 90 and under 114 mmHg at Visit 1
    • In case of not using any antihypertensives, mean seated DBP* must be over 95 and under 114 mmHg at Visit 1
    • Mean seated DBP* must be over 90 at Visit 2 (* The mean DBP values will be calculated as the average of three seated measurements taken at two-minute intervals).
  2. Age over 20 and under 80 years at Visit 1 (Male or Female)
  3. Outpatient
  4. Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
  5. Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.

1. Patients taking four or more anti-hypertensive medications at Visit 1 2. Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.) 3. Patients whose mean seated DBP > 114 mmHg and/or mean seated SBP > 200 mmHg at Visit 1, Visit 2 or Visit 3 4. Patients with sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias (AV-block II-III, atrial fibrillation etc.) 5. Patients with NYHA functional class heart failure III-IV 6. Patients with a history of myocardial infarction or cardiac surgery within last 6 3 months before signing the informed consent form 7. Patients with a history of coronary artery bypass surgery or percutaneous transluminal coronary angioplasty (PTCA) within last 3 months before signing the informed consent form 8. Patients with a history of unstable angina within last 3 months before signing the informed consent form 9. Patients with hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve 10. Patients with a history of stroke or transient ischemic attack within last 6 months before signing the informed consent form 11. Patients with a history of sudden exacerbation of renal function with AT1 receptor antagonists or ACE inhibitors; post-renal transplant 12. Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with AT1 receptor antagonists or ACE inhibitors 13. Patients with known hypersensitivity to any component of the formulation, or a known hypersensitivity to sulfonamides or sulfonamide-derived drugs (e.g. thiazides) 14. Known, suspected or history of gout

  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: NCT00326768

Locations
Japan
Boehringer Ingelheim Investigational Site
Hiroshima-shi, Hiroshima, Japan, 733-0011
Boehringer Ingelheim Investigational Site
Sapporo-shi, Hokkaido, Japan, 060-0003
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan, 160-0023
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Nippon Boehringer Ingelheim Co., Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00326768     History of Changes
Other Study ID Numbers: 502.516
Study First Received: May 16, 2006
Last Updated: November 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 28, 2014