Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to assess the efficacy and safety of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other antihypertensive therapies during open-label, long-term treatment.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Hydrochlorothiazide; Telmisartan; Telmisartan, hydrochlorothiazide drug combination

Criteria

Inclusion criteria:

• Essential hypertension.

• Currently taking between one and three antihypertensive medications at a stable dose for at least four weeks before Visit 1 of preceding trial 502.480.

• Blood pressure not adequately controlled on existing treatment before entry to preceding trial 502.480 (inadequate control defined as seated DBP >= 95 mmHg on one current antihypertensive medication or DBP >= 90 mmHg on two or more current antihypertensive medications).

• Failure to respond to six weeks run-in treatment with T80/H12.5 in preceding trial 502.480. (Failure to respond defined as seated DBP >= 90 mmHg.)

• Willing and able to provide written informed consent.

Exclusion criteria:

• Women of child-bearing potential NOT practising acceptable means of birth control, positive serum pregnancy test, breastfeeding.

• Known or suspected secondary hypertension.

• Clinically significant change in ECG reported as adverse event in preceding trial 502.480.

• Any medical condition developing in preceding trial 502.480 that could be worsened by telmisartan/HCTZ (80/25).

• Discontinuation from preceding 502.480 trial for adverse event or any other reason.

• Mean SBP >= 200 mmHg.

• Severe hepatic or renal impairment.

• Bilateral renal artery stenosis (or in a solitary kidney), post-renal transplant or only one functioning kidney.

• Clinically relevant hypokalaemia or hyperkalaemia.

• Uncorrected volume or sodium depletion, primary aldosteronism.

• Hereditary fructose intolerance.

• Previous symptoms of angioedema after ACE inhibitors or angiotensin-II receptor antagonists.

• Drug or alcohol dependency within the six months prior to entry to 502.480. concurrent participation in another clinical trial or any investigational therapy.

• Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.

• Allergic hypersensitivity to any component of the formulations under investigation.

• Concomitant therapy with lithium, cholestyramine or colestipol resins.

• Non-compliance with study medication (less than 80% or more than 120%) during the preceding 502.480 trial.

• Any other clinical condition which, in the opinion of the investigator, would not allow safe administration of telmisartan or hydrochlorothiazide.