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

NCT00239369 | Completed Phase 3

• 1 other identifier: 502.480
• Study Type: interventional
• Target: 713
• Locations: 16 countries
• Sites: 84

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in trough seated DBP

  8 weeks

Secondary Outcomes (7)

• Change from baseline in trough seated SBP

  8 weeks

• Change from baseline in trough standing DBP and SBP

  8 weeks

• The proportion of patients achieving DBP control (trough seated DBP<90 mmHg).

  8 weeks

• The proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg).

  8 weeks

• The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg).

  8 weeks

Interventions

Fixed dose combination telmisartan 80 mg + HCTZ 25 mg DRUG

Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (84)

Boehringer Ingelheim Investigational Site

Birker?d, 3460, Denmark

Location

Boehringer Ingelheim Investigational Site

Haderslev, DK-6100, Denmark

Location

Boehringer Ingelheim Investigational Site

Odder, DK-8300, Denmark

Location

Boehringer Ingelheim Investigational Site

R?dovre, DK-2610, Denmark

Location

Boehringer Ingelheim Investigational Site

Vildbjerg, DK-7480, Denmark

Location

Boehringer Ingelheim Investigational Site

Helsinki, FI-00500, Finland

Location

Boehringer Ingelheim Investigational Site

Joensuu, FI-80100, Finland

Location

Boehringer Ingelheim Investigational Site

Kokkola, FI-67200, Finland

Location

Boehringer Ingelheim Investigational Site

Turku, FI-20100, Finland

Location

Boehringer Ingelheim Investigational Site

Turku, FI-20520, Finland

Location

ALTI

Angers, 49000, France

Location

ALTI

Angers, 49100, France

Location

Hopital Avicenne

Bobigny, 93000, France

Location

Mg Recherches

Paris, 75015, France

Location

Boehringer Ingelheim Investigational Site

Ellefeld, 08236, Germany

Location

Boehringer Ingelheim Investigational Site

Flörsheim, 65439, Germany

Location

Boehringer Ingelheim Investigational Site

Frankfurt am Main, 60323, Germany

Location

Boehringer Ingelheim Investigational Site

Haag, 83527, Germany

Location

Boehringer Ingelheim Investigational Site

Ingelheim, 55218, Germany

Location

Boehringer Ingelheim Investigational Site

Nuremberg, 90402, Germany

Location

Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, 63110, Germany

Location

Boehringer Ingelheim Investigational Site

Unterschneidheim, 73485, Germany

Location

Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

Boehringer Ingelheim Investigational Site

Birr, Ireland

Location

Boehringer Ingelheim Investigational Site

Carrigallen, Ireland

Location

Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

Boehringer Ingelheim Investigational Site

Enniscorthy, Ireland

Location

Boehringer Ingelheim Investigational Site

Gorey, Ireland

Location

Boehringer Ingelheim Investigational Site

Mallow, Ireland

Location

Boehringer Ingelheim Investigational Site

New Ross, Ireland

Location

Boehringer Ingelheim Investigational Site

Toomyvara, Ireland

Location

Ospedale Arnaboldi

Broni (PV), 27043, Italy

Location

Azienda Ospedaliera Universita di Ferrara

Ferrara, 44100, Italy

Location

IRCCS San Raffaele

Roma, 00163, Italy

Location

Ospedale Civile

Vittorio Veneto (TV), 31029, Italy

Location

Boehringer Ingelheim Investigational Site

Kuching, Sarawak, 93586, Malaysia

Location

Boehringer Ingelheim Investigational Site

Bennebroek, 2121 BB, Netherlands

Location

Boehringer Ingelheim Investigational Site

Ewijk, 6644 CL, Netherlands

Location

Boehringer Ingelheim Investigational Site

Helmond, 5704 CM, Netherlands

Location

Boehringer Ingelheim Investigational Site

Hoogwoud, 1817 BG, Netherlands

Location

Boehringer Ingelheim Investigational Site

Nijverdal, 7442 LS, Netherlands

Location

Boehringer Ingelheim Investigational Site

Oude Pekela, 9665 AR, Netherlands

Location

Boehringer Ingelheim Investigational Site

Oude Pekela, 9665 BJ, Netherlands

Location

Boehringer Ingelheim Investigational Site

Rijswijk, 2281 AK, Netherlands

Location

Boehringer Ingelheim Investigational Site

Roelofarendsveen, 2371 RB, Netherlands

Location

Boehringer Ingelheim Investigational Site

Rotterdam, 3082 DC, Netherlands

Location

Boehringer Ingelheim Investigational Site

Elverum, N-2408, Norway

Location

Boehringer Ingelheim Investigational Site

Moelv, N-2391, Norway

Location

Boehringer Ingelheim Investigational Site

Oslo, N-0369, Norway

Location

Boehringer Ingelheim Investigational Site

Skedsmokorset, N-2020, Norway

Location

Boehringer Ingelheim Investigational Site

Tolvsr?d, N-3153, Norway

Location

Boehringer Ingelheim Investigational Site

Bellville, 7531, South Africa

Location

Boehringer Ingelheim Investigational Site

Durban, 4091, South Africa

Location

Boehringer Ingelheim Investigational Site

Johannesburg, 2001, South Africa

Location

Boehringer Ingelheim Investigational Site

Johannesburg, 2013, South Africa

Location

Boehringer Ingelheim Investigational Site

Lenasia, 2033, South Africa

Location

Boehringer Ingelheim Investigational Site

Lenasia South, 2033, South Africa

Location

Boehringer Ingelheim Investigational Site

Midrand, 1685, South Africa

Location

Boehringer Ingelheim Investigational Site

Pretoria, 0038, South Africa

Location

Boehringer Ingelheim Investigational Site

Incheon, 405760, South Korea

Location

Boehringer Ingelheim Investigational Site

Seoul, 134701, South Korea

Location

Boehringer Ingelheim Investigational Site

Seoul, 152703, South Korea

Location

Hospital Municipal de Badalona

Badalona / Barcelona, 08911, Spain

Location

Hospital de Galdakao

Galdakao / Vizcaya, 48680, Spain

Location

Hospital Gral. Jerez de la Frontera

Jerez de La Frontera / Cadiz, 11407, Spain

Location

C.A.P. Mosen Cinto Verdaguer

L'Hospitalet de Llobregat / Barcelona, 08902, Spain

Location

Hospital Universitario Gregorio Mara?on

Madrid, 28007, Spain

Location

C.A.P. Ronda Cerdanya

Mataro (Barcelona), 08303, Spain

Location

Hospital General de Mostoles - Medicina Interna

Mostoles / Madrid, 28935, Spain

Location

Hospital del Conxo

Santiago de Compostela, 15706, Spain

Location

Boehringer Ingelheim Investigational Site

Eksjö, 575 36, Sweden

Location

Boehringer Ingelheim Investigational Site

Karlstad, 651 85, Sweden

Location

Boehringer Ingelheim Investigational Site

Karlstad, 652 24, Sweden

Location

Boehringer Ingelheim Investigational Site

Uddevalla, 451 40, Sweden

Location

Boehringer Ingelheim Investigational Site

Uppsala, 751 25, Sweden

Location

Boehringer Ingelheim Investigational Site

Basel, 4031, Switzerland

Location

Boehringer Ingelheim Investigational Site

Basel, 4051, Switzerland

Location

Boehringer Ingelheim Investigational Site

Basel, 4052, Switzerland

Location

Boehringer Ingelheim Investigational Site

Bellinzona, 6500, Switzerland

Location

Boehringer Ingelheim Investigational Site

Saint-Imier, 2610, Switzerland

Location

Boehringer Ingelheim Investigational Site

Vezia, 6943, Switzerland

Location

Boehringer Ingelheim Investigational Site

Taipei, 104, Taiwan

Location

Boehringer Ingelheim Investigational Site

Taipei, 112, Taiwan

Location

Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  BIL UK / Ireland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: October 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: December 28, 2017

Record last verified: 2017-12

Locations

MY (1); NL (10); FR (4); SE (5); KR (3); FI (5); IT (4); CH (6); NO (5); HK (1); IE (8); ZA (8); TW (3); DK (5); DE (8); ES (8)