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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00239369
First received: October 13, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Fixed dose combination telmisartan 80 mg + HCTZ 25 mg
Drug: Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg
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: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in trough seated DBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in trough seated SBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in trough standing DBP and SBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients achieving DBP control (trough seated DBP<90 mmHg). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 713
Study Start Date: October 2005
Estimated Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00239369

  Show 86 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BIL UK / Ireland
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00239369     History of Changes
Other Study ID Numbers: 502.480
Study First Received: October 13, 2005
Last Updated: October 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Italy: Comitato Etico dell'Azienda Ospedaliera Arcispedale Sant'Anna - Universit?di Ferrara
Switzerland: Swissmedic
Netherlands: No regulatory agency approval needed for clinical trials
Finland: National Agency for Medicines, Mannerheimintie 103b, P.O.Box 55, FI-00301 Helsinki,
Denmark: Laegemiddelstyrelsen Clinical Studies
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
South Africa: Medicines Control Council

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

ClinicalTrials.gov processed this record on July 24, 2014