Clinical trial NCT00326768 (phase 3, status: completed)
Conditions: hypertension
ICD codes: I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10
Drugs: telmisartan 40 mg/hctz 12.5 mg, telmisartan 40 mg, telmisartan 80 mg/hctz 12.5 mg
SMILES: CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O, CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O, CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O
Eligibility 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