Telmisartan80/HCTZ25 Versus Telmisartan80/HCTZ12.5 in Hypertension Not Responding to Telmisartan80/HCTZ12.5

December 27, 2017 updated by: Boehringer Ingelheim

A Prospective Randomised Study to Compare a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 25 mg With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Uncontrolled Hypertension Who Fail to Respond Adequately to Treatment With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg

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 weeks compared with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) in patients who fail to respond to six weeks treatment with T80/H12.5.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 seventeen countries will enter the screening part of the study and approximately 480 of these patients will be allocated to double-blind randomised study treatment. The study will last for approximately fifteen weeks. Patients will visit the study doctor five times for assessment. After informed consent, patients will start a screening period for four to ten days. During the screening period, patients must take their usual blood pressure treatment but will stop this by the date of the next visit. If the patient is suitable for this study, they will then start run-in treatment period with telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) taken as a single tablet once per day for approximately six weeks.

At the end of the run-in treatment period, if the diastolic blood pressure (DBP) is below 90 mmHg, the patient will not proceed as their blood pressure is already controlled by T80/H12.5. If the DBP is 90 mmHg or greater they will start the randomised study treatment period and be randomly allocated to double-blind treatment with either telmisartan 80 mg plus hydrochlorothiazide 25 mg(T80/H25) or T80/H12.5 taken as a single tablet once per day for eight weeks. They will also receive a placebo tablet (a dummy tablet which contains no active ingredient) every day.

They will visit the clinic four weeks and eight weeks later for assessment of their blood pressure and general health. Their participation in the study is complete eight weeks after the start of the randomised treatment period.

Study Hypothesis:

The trial hypothesis is that the reduction in seated trough DBP (i.e., seated trough DBP at the end of the randomised treatment period compared with the seated trough DBP at the start of the randomised treatment period) will be greater in the T80/H25 group compared with the T80/H12.5 group.

Comparison(s):

The efficacy and safety of the two trial treatments (T80/H25 versus T80/H12.5) will be compared. Trough blood pressure is the blood pressure 24 hours after the last dose of trial medication.

Study Type

Interventional

Enrollment

713

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Birker?d, Denmark, 3460
        • Boehringer Ingelheim Investigational Site
      • Haderslev, Denmark, DK-6100
        • Boehringer Ingelheim Investigational Site
      • Odder, Denmark, DK-8300
        • Boehringer Ingelheim Investigational Site
      • R?dovre, Denmark, DK-2610
        • Boehringer Ingelheim Investigational Site
      • Vildbjerg, Denmark, DK-7480
        • Boehringer Ingelheim Investigational Site
  • Finland
      • Helsinki, Finland, FI-00500
        • Boehringer Ingelheim Investigational Site
      • Joensuu, Finland, FI-80100
        • Boehringer Ingelheim Investigational Site
      • Kokkola, Finland, FI-67200
        • Boehringer Ingelheim Investigational Site
      • Turku, Finland, FI-20100
        • Boehringer Ingelheim Investigational Site
      • Turku, Finland, FI-20520
        • Boehringer Ingelheim Investigational Site
  • France
      • Angers, France, 49000
        • ALTI
      • Angers, France, 49100
        • ALTI
      • Bobigny, France, 93000
        • Hôpital Avicenne
      • Paris, France, 75015
        • Mg Recherches
  • Germany
      • Ellefeld, Germany, 08236
        • Boehringer Ingelheim Investigational Site
      • Florsheim, Germany, 65439
        • Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Germany, 60323
        • Boehringer Ingelheim Investigational Site
      • Haag, Germany, 83527
        • Boehringer Ingelheim Investigational Site
      • Ingelheim, Germany, 55218
        • Boehringer Ingelheim Investigational Site
      • Nurnberg, Germany, 90402
        • Boehringer Ingelheim Investigational Site
      • Rodgau-Dudenhofen, Germany, 63110
        • Boehringer Ingelheim Investigational Site
      • Unterschneidheim, Germany, 73485
        • Boehringer Ingelheim Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Boehringer Ingelheim Investigational Site
  • Ireland
      • Birr, Ireland
        • Boehringer Ingelheim Investigational Site
      • Carrigallen, Ireland
        • Boehringer Ingelheim Investigational Site
      • Dublin 18, Ireland
        • Boehringer Ingelheim Investigational Site
      • Dublin 24, Ireland
        • Boehringer Ingelheim Investigational Site
      • Dublin 9, Ireland
        • Boehringer Ingelheim Investigational Site
      • Enniscorthy,, Ireland
        • Boehringer Ingelheim Investigational Site
      • Gorey, Ireland
        • Boehringer Ingelheim Investigational Site
      • Mallow, Ireland
        • Boehringer Ingelheim Investigational Site
      • New Ross, Ireland
        • Boehringer Ingelheim Investigational Site
      • Toomevara, Ireland
        • Boehringer Ingelheim Investigational Site
  • Italy
      • Broni (PV), Italy, 27043
        • Ospedale Arnaboldi
      • Ferrara, Italy, 44100
        • Azienda Ospedaliera Universita di Ferrara
      • Roma, Italy, 00163
        • IRCCS San Raffaele
      • Vittorio Veneto (TV), Italy, 31029
        • Ospedale Civile
  • Korea, Republic of
      • Incheon, Korea, Republic of, 405760
        • Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of, 134701
        • Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of, 152703
        • Boehringer Ingelheim Investigational Site
  • Malaysia
      • Kuching, Sarawak, Malaysia, 93586
        • Boehringer Ingelheim Investigational Site
  • Netherlands
      • Bennebroek, Netherlands, 2121 BB
        • Boehringer Ingelheim Investigational Site
      • Ewijk, Netherlands, 6644 CL
        • Boehringer Ingelheim Investigational Site
      • Helmond, Netherlands, 5704 CM
        • Boehringer Ingelheim Investigational Site
      • Hoogwoud, Netherlands, 1817 BG
        • Boehringer Ingelheim Investigational Site
      • Nijverdal, Netherlands, 7442 LS
        • Boehringer Ingelheim Investigational Site
      • Oude Pekela, Netherlands, 9665 BJ
        • Boehringer Ingelheim Investigational Site
      • Oude Pekela, Netherlands, 9665 AR
        • Boehringer Ingelheim Investigational Site
      • Rijswijk, Netherlands, 2281 AK
        • Boehringer Ingelheim Investigational Site
      • Roelofarendsveen, Netherlands, 2371 RB
        • Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands, 3082 DC
        • Boehringer Ingelheim Investigational Site
  • Norway
      • Elverum, Norway, N-2408
        • Boehringer Ingelheim Investigational Site
      • Moelv, Norway, N-2391
        • Boehringer Ingelheim Investigational Site
      • Oslo, Norway, N-0369
        • Boehringer Ingelheim Investigational Site
      • Skedsmokorset, Norway, N-2020
        • Boehringer Ingelheim Investigational Site
      • Tolvsr?d, Norway, N-3153
        • Boehringer Ingelheim Investigational Site
  • South Africa
      • Bellville, South Africa, 7531
        • Boehringer Ingelheim Investigational Site
      • Durban, South Africa, 4091
        • Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa, 2001
        • Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa, 2013
        • Boehringer Ingelheim Investigational Site
      • Lenasia, South Africa, 2033
        • Boehringer Ingelheim Investigational Site
      • Lenasia South, South Africa, 2033
        • Boehringer Ingelheim Investigational Site
      • Midrand, South Africa, 1685
        • Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa, 0038
        • Boehringer Ingelheim Investigational Site
  • Spain
      • Badalona / Barcelona, Spain, 08911
        • Hospital Municipal de Badalona
      • Galdakao / Vizcaya, Spain, 48680
        • Hospital de Galdakao
      • Jerez De La Frontera / Cadiz, Spain, 11407
        • Hospital Gral. Jerez de la Frontera
      • L'Hospitalet De Llobregat / Barcelona, Spain, 08902
        • C.A.P. Mosen Cinto Verdaguer
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Mara?on
      • Mataro (Barcelona), Spain, 08303
        • C.A.P. Ronda Cerdanya
      • Mostoles / Madrid, Spain, 28935
        • Hospital General de Mostoles - Medicina Interna
      • Santiago de Compostela, Spain, 15706
        • Hospital del Conxo
  • Sweden
      • Eksjo, Sweden, 575 36
        • Boehringer Ingelheim Investigational Site
      • Karlstad, Sweden, 651 85
        • Boehringer Ingelheim Investigational Site
      • Karlstad, Sweden, 652 24
        • Boehringer Ingelheim Investigational Site
      • Uddevalla, Sweden, 451 40
        • Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden, 751 25
        • Boehringer Ingelheim Investigational Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Boehringer Ingelheim Investigational Site
      • Basel, Switzerland, 4051
        • Boehringer Ingelheim Investigational Site
      • Basel, Switzerland, 4052
        • Boehringer Ingelheim Investigational Site
      • Bellinzona, Switzerland, 6500
        • Boehringer Ingelheim Investigational Site
      • St. Imier, Switzerland, 2610
        • Boehringer Ingelheim Investigational Site
      • Vezia, Switzerland, 6943
        • Boehringer Ingelheim Investigational Site
  • Taiwan
      • Taipei, Taiwan
        • Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan, 112
        • Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan, 104
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in trough seated DBP
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in trough seated SBP
Time Frame: 8 weeks
8 weeks
Change from baseline in trough standing DBP and SBP
Time Frame: 8 weeks
8 weeks
The proportion of patients achieving DBP control (trough seated DBP<90 mmHg).
Time Frame: 8 weeks
8 weeks
The proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg).
Time Frame: 8 weeks
8 weeks
The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg).
Time Frame: 8 weeks
8 weeks
The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg)
Time Frame: 8 weeks
8 weeks
The proportion of patients in trough seated BP categories: opt.: SBP<120 mmHg and DBP<80 mmHg., norm.: SBP<130 mmHg and DBP<85 mmHg and not optimal, high-normal: SBP<140 mmHg and DBP<90 mmHg and not optimal or normal, high: SBP ≥140 mmHg or DBP ≥90 mmHg
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Actual)

December 28, 2017

Last Update Submitted That Met QC Criteria

December 27, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.480

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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