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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00146341
First received: September 5, 2005
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Hypertension
Drug: Telmisartan/HCTZ
Drug: Telmisartan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 345
Study Start Date: April 2005
Estimated Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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.

Comparison(s):

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146341

Locations
China
Peking Union Medical College Hospital
Beijing, China, 100730
Beijing Tiantan Hospital
Beijing, China, 100050
China-Japan Friendship Hospital
Beijing, China, 100029
No. 1 Hospital Affiliated Nanjing
Nanjing, China, 210006
Shanghai Changhai Hospital
Shanghai, China, 200433
Ruijin Hospital, School of Medicine
Shanghai, China, 200025
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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00146341     History of Changes
Other Study ID Numbers: 502.472
Study First Received: September 5, 2005
Last Updated: November 18, 2013
Health Authority: China: State Food and Drug Administrative

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 20, 2014