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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326768
• Other study ID #: 502.516
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2006
• Last updated: December 27, 2017
• Start date: May 2006
• Est. completion date: August 2007

Study information

• Verified date: December 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Telmisartan 40 mg/HCTZ 12.5 mg

• Telmisartan 40 mg

• Telmisartan 80 mg/HCTZ 12.5 mg

Locations

Country	Name	City	State
Japan	Boehringer Ingelheim Investigational Site	Hiroshima-shi, Hiroshima
Japan	Boehringer Ingelheim Investigational Site	Sapporo-shi, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		52 weeks
Primary	Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)		52 weeks
Primary	Changes in electrocardiogram (ECG)		52 weeks
Primary	Changes in blood pressure and pulse rate		52 weeks
Secondary	Seated Diastolic Blood Pressure (DBP) control rate		after 12 and 52 weeks
Secondary	Seated Systolic Blood Pressure (SBP) control rate		after 12 and 52 weeks
Secondary	Seated DBP response rate		after 12 and 52 weeks
Secondary	Seated SBP response rate		after 12 and 52 weeks
Secondary	Seated blood pressure (BP) normality criteria		after 12 and 52 weeks
Secondary	Changes in seated DBP		after 12 and 52 weeks
Secondary	Changes in seated SBP		after 12 and 52 weeks

External Links

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