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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00146341
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : December 28, 2017
Information provided by:
Boehringer Ingelheim

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, in lowering seated trough diastolic blood pressure after eight weeks of treatment.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan/HCTZ Drug: Telmisartan Phase 3

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 telmisartan monotherapy.

All patients will enter a one-week screening phase prior to starting the eight-week open-label T80 mg period. At the end of four weeks, only patients who fail to respond to T80 mg (DBP >= 90 mm Hg) will continue the treatment with T80 mg for another four weeks. At the end of eight weeks, only patients who fail to respond to T80 mg (DBP >= 90 mm Hg) will be randomized, double-blind, to receive either T80 mg alone or the fixed dose combination of T80 mg plus HCTZ 12.5 mg for eight weeks. Seated BP will be taken 24 hours post-dose at each visit. Labs, ECG, and physical examination will be done at screening, at baseline and at the final visit.

Study Hypothesis:

The primary objective of the study, showing that fixed dose combination is superior to telmisartan 80 mg alone will be tested using the hypotheses given below.

H0: u T80/H12.5 - uT80 = 0 mm Hg versus H1: uT80/H12.5 - uT80 not equal 0 mm Hg, where uT80/H12.5 anduT80 represent the average reduction from baseline (Visit 4) in trough seated DBP for the fixed dose combination and telmisartan 80 mg, respectively.

Testing of the null hypothesis will be performed using a two-sided test of significance at an a-level (type-I error rate) of 0.05.


The primary efficacy endpoint will be the change from baseline in seated DBP 24 hours post-dose at the last visit during the double-blind treatment phase. The pre-dose measurement on visit 4 will be viewed as the baseline measurement.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Eight Week Randomized, Double-Blind, Double-Dummy Study Comparing a Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 12.5mg to Telmisartan 80mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 80mg.
Study Start Date : April 2005
Actual Primary Completion Date : September 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Primary Outcome Measures :
  1. The primary efficacy variable is change from baseline in seated DBP at trough (24 hours post-dosing) after eight weeks of randomized treatment or at last trough observation during the double-blind phase (i.e. last trough observation carried forward).

Secondary Outcome Measures :
  1. Change from baseline in seated SBP, standing DBP and SBP at trough after eight weeks of randomized treatment or at last trough observation during the double-blind phase. The percentage of patients responding to the treatment. Safety.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146341

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China-Japan Friendship Hospital
Beijing, China, 100029
Beijing Tiantan Hospital
Beijing, China, 100050
Peking Union Medical College Hospital
Beijing, China, 100730
No. 1 Hospital Affiliated Nanjing
Nanjing, China, 210006
Ruijin Hospital, School of Medicine
Shanghai, China, 200025
Shanghai Changhai Hospital
Shanghai, China, 200433
254 PLA Hospital
Tianjin, China, 300150
Second Hospital Affiliated to Tianjin Med University
Tianjin, China, 300211
No. 1 Hosp Affiliated to Med College
Zhejiang Province, China, 310003
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
Additional Information:
Layout table for additonal information Identifier: NCT00146341    
Other Study ID Numbers: 502.472
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action