Status:
COMPLETED
Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 80 mg in Patients Failed in Telmisartan 80 mg
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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,...
Detailed Description
This is a multi-centre, prospective, randomized, double-blind, parallel-group study in approximately 244 patients with a history of mild-to-moderate hypertensive who have been shown not to respond to ...
Eligibility Criteria
Inclusion
- History of mild-to-moderate hypertension defined by a mean seated DBP \>=95 and \<= 109 mmHg before inclusion in the open-label phase
- Patients who fail to respond adequately to telmisartan monotherapy (mean seated DBP \>= 90 mmHg)
- Participants between 18 and 80 years of age
- Ability to provide written informed consent
Exclusion
- Patients taking more than three anti-hypertensive medications at the screening visit.
- 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)
- Any woman:
- Who has a positive urine pregnancy test at screening (Visit 1)
- Who is nursing
- 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
- Clinically relevant hypokalaemia or hyperkalaemia
- Uncorrected volume depletion
- Uncorrected sodium depletion
- Primary aldosteronism
- Hereditary fructose intolerance
- Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency
- Known or suspected secondary hypertension
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
- Congestive heart failure (NYHA functional class CHF III-IV)
- Unstable angina within the past three months
- Stroke within the past six months
- Myocardial infarction or cardiac surgery within the past three months
- PTCA within the past three months
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00146341
Start Date
April 1 2005
End Date
September 1 2006
Last Update
December 28 2017
Active Locations (9)
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1
China-Japan Friendship Hospital
Beijing, China, 100029
2
Beijing Tiantan Hospital
Beijing, China, 100050
3
Peking Union Medical College Hospital
Beijing, China, 100730
4
No. 1 Hospital Affiliated Nanjing
Nanjing, China, 210006