Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 80 mg in Patients Failed in Telmisartan 80 mg

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg is superior to telmisartan 80 mg alone in patients, who fail to respond adequately to telmisartan 80 mg monotherapy, in lowering seated trough diastolic blood pressure after eight weeks of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Hydrochlorothiazide; Telmisartan

Criteria

Inclusion Criteria:

1. History of mild-to-moderate hypertension defined by a mean seated DBP >=95 and <= 109 mmHg before inclusion in the open-label phase

2. Patients who fail to respond adequately to telmisartan monotherapy (mean seated DBP >= 90 mmHg)

3. Participants between 18 and 80 years of age

4. Ability to provide written informed consent

Exclusion Criteria:

1. Patients taking more than three anti-hypertensive medications at the screening visit.

2. Pre-menopausal women (last menstruation 1 year prior to start of screening):

• Who are not surgically sterile (hysterectomy, tubal ligation)

• Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study (acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives)

3. Any woman:

• Who has a positive urine pregnancy test at screening (Visit 1)

• Who is nursing

4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

• SGPT(ALT) or SGOT(AST) greater than two times the upper limit of normal

• Serum creatinine > 3.0 mg/dL (or 265 mol/L) or creatinine clearance < 0.6 ml/sec

5. Clinically relevant hypokalaemia or hyperkalaemia

6. Uncorrected volume depletion

7. Uncorrected sodium depletion

8. Primary aldosteronism

9. Hereditary fructose intolerance

10. Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency

11. Known or suspected secondary hypertension

12. Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney

13. Congestive heart failure (NYHA functional class CHF III-IV)

14. Unstable angina within the past three months

15. Stroke within the past six months

16. Myocardial infarction or cardiac surgery within the past three months

17. PTCA within the past three months