Status:
COMPLETED
Telmisartan80/HCTZ25 Versus Telmisartan80/HCTZ12.5 in Hypertension Not Responding to Telmisartan80/HCTZ12.5
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg (T80/H25) is superior in reducing blood pressure after eight wee...
Detailed Description
Adult patients with high blood pressure who are currently taking one, two or three blood pressure treatments will be asked to take part in the study. It is expected that about 1,600 patients in sevent...
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.
- Blood pressure not adequately controlled on existing treatment before entry (inadequate control defined as seated DBP \>= 95 mmHg on one current antihypertensive medication or DBP \>= 90 mmHg on two or more current antihypertensive medication(s).
- Failure to respond to six weeks treatment with T80/H12.5. (Failure to respond defined as seated DBP \>= 90 mmHg at six weeks. This criterion will be assessed at Visit 3.)
- 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.
- 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 previous six months.
- Administration of any medication known to affect blood pressure.
- 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 th e run-in treatment period.
- 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 :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
713 Patients enrolled
Trial Details
Trial ID
NCT00239369
Start Date
October 1 2005
End Date
August 1 2006
Last Update
December 28 2017
Active Locations (84)
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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, DK-8300
4
Boehringer Ingelheim Investigational Site
R?dovre, Denmark, DK-2610