Status:
COMPLETED
Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 thera...
Detailed Description
Patients with a history of hypertension who completed a preceding trial (number 502.480) within the previous fourteen (14) days will be considered for entry to this long-term open-label trial. All pat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
639 Patients enrolled
Trial Details
Trial ID
NCT00267943
Start Date
January 1 2006
End Date
January 1 2007
Last Update
November 13 2013
Active Locations (78)
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1
Boehringer Ingelheim Investigational Site
Birker?d, Denmark, 3460
2
Boehringer Ingelheim Investigational Site
Haderslev, Denmark, DK-6100
3
Boehringer Ingelheim Investigational Site
Odder, Denmark, 8300
4
Boehringer Ingelheim Investigational Site
R?dovre, Denmark, DK-2600