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HypertensionPhase 3NCT00326768

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

A Phase 3 study testing Telmisartan 40 mg/HCTZ 12.5 mg, Telmisartan 40 mg and Telmisartan 80 mg/HCTZ 12.5 mg in people with Hypertension, run by Boehringer Ingelheim at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Hypertension
What is being tested?
Telmisartan 40 mg/HCTZ 12.5 mg, Telmisartan 40 mg and Telmisartan 80 mg/HCTZ 12.5 mg
How many people
184 participants
Where
3 sitesJapan
Study dates
May 2006to Aug 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  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).
  1. Age over 20 and under 80 years at Visit 1 (Male or Female)
  2. Outpatient
  3. Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
  4. 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.
  5. 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

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • Boehringer Ingelheim Investigational Site

    Hiroshima-shi, Hiroshima, 733-0011

  • Boehringer Ingelheim Investigational Site

    Sapporo-shi, Hokkaido, 060-0003

  • Boehringer Ingelheim Investigational Site

    Shinjuku-ku, Tokyo, 160-0023

Other trials in Japan

About this study

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

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.

Read the 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.

Conditions
Hypertension
Being tested
Telmisartan 40 mg/HCTZ 12.5 mg, Telmisartan 40 mg, Telmisartan 80 mg/HCTZ 12.5 mg
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telmisartan 40 mg/HCTZ 12.5 mgDrug

  • Telmisartan 40 mgDrug

  • Telmisartan 80 mg/HCTZ 12.5 mgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Measured: 52 weeks

  2. Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)

    Measured: 52 weeks

  3. Changes in electrocardiogram (ECG)

    Measured: 52 weeks

  4. Changes in blood pressure and pulse rate

    Measured: 52 weeks

Secondary outcomes (7)

  1. Seated Diastolic Blood Pressure (DBP) control rate

    Measured: after 12 and 52 weeks

  2. Seated Systolic Blood Pressure (SBP) control rate

    Measured: after 12 and 52 weeks

  3. Seated DBP response rate

    Measured: after 12 and 52 weeks

  4. Seated SBP response rate

    Measured: after 12 and 52 weeks

  5. Seated blood pressure (BP) normality criteria

    Measured: after 12 and 52 weeks

  6. Changes in seated DBP

    Measured: after 12 and 52 weeks

  7. Changes in seated SBP

    Measured: after 12 and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionAug 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00326768
Sponsor's protocol ID
502.516
Status last verified
Dec 2017
First submitted
16 May 2006
Last updated
28 Dec 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telmisartan 40 mg/HCTZ 12.5 mg, Telmisartan 40 mg and Telmisartan 80 mg/HCTZ 12.5 mg in people with Hypertension, run by Boehringer Ingelheim at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00326768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.

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