CompletedNCT00326768Updated Dec 28, 2017

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

A Phase 3 interventional study of Telmisartan 40 mg/HCTZ 12.5 mg and Telmisartan 40 mg in Hypertension, sponsored by Boehringer Ingelheim. Completed at 3 sites in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-28.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 184
Allocation: Non-randomized
Ages: 20 Years to 80 Years
Sex: All

Study 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 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 studied

Hypertension

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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 184 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

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Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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).
Age over 20 and under 80 years at Visit 1 (Male or Female)
Outpatient
Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
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.

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 184 participants (actual)

Interventions

DrugTelmisartan 40 mg/HCTZ 12.5 mg
DrugTelmisartan 40 mg
DrugTelmisartan 80 mg/HCTZ 12.5 mg

What researchers measure

Primary outcomes

Incidence of adverse events
Time frame: 52 weeks
Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)
Time frame: 52 weeks
Changes in electrocardiogram (ECG)
Time frame: 52 weeks
Changes in blood pressure and pulse rate
Time frame: 52 weeks

Secondary outcomes

Seated Diastolic Blood Pressure (DBP) control rate
Time frame: after 12 and 52 weeks
Seated Systolic Blood Pressure (SBP) control rate
Time frame: after 12 and 52 weeks
Seated DBP response rate
Time frame: after 12 and 52 weeks
Seated SBP response rate
Time frame: after 12 and 52 weeks
Seated blood pressure (BP) normality criteria
Time frame: after 12 and 52 weeks
Changes in seated DBP
Time frame: after 12 and 52 weeks
Changes in seated SBP
Time frame: after 12 and 52 weeks

Study locations

3 sites

Boehringer Ingelheim Investigational Site
Hiroshima-shi, Hiroshima, 733-0011, Japan
Boehringer Ingelheim Investigational Site
Sapporo-shi, Hokkaido, 060-0003, Japan
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, 160-0023, Japan

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00326768
Lead sponsor: Boehringer Ingelheim
First posted: May 17, 2006
Start date: May 2006
Primary completion: Aug 2007
Completion: Aug 2007
Last update: Dec 28, 2017

Study contacts

Boehringer Ingelheim Study Coordinator

study chair · Nippon Boehringer Ingelheim Co., Ltd.

View the source record on ClinicalTrials.gov ↗

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