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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00239369
• Collaborator: (none)
• Enrollment: 713
• Locations: 86
• Duration (Months): 10
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Aug 1, 2006
• Study Completion Date: Aug 1, 2006

Outcome Measures

Primary Outcome Measures

1. Change from baseline in trough seated DBP [8 weeks]

Secondary Outcome Measures

1. Change from baseline in trough seated SBP [8 weeks]

2. Change from baseline in trough standing DBP and SBP [8 weeks]

3. The proportion of patients achieving DBP control (trough seated DBP<90 mmHg). [8 weeks]

4. The proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg). [8 weeks]

5. The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg). [8 weeks]

6. The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg) [8 weeks]

7. 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 [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Boehringer Ingelheim Investigational Site	Birker?d		Denmark	3460
2	Boehringer Ingelheim Investigational Site	Haderslev		Denmark	DK-6100
3	Boehringer Ingelheim Investigational Site	Odder		Denmark	DK-8300
4	Boehringer Ingelheim Investigational Site	R?dovre		Denmark	DK-2610
5	Boehringer Ingelheim Investigational Site	Vildbjerg		Denmark	DK-7480
6	Boehringer Ingelheim Investigational Site	Helsinki		Finland	FI-00500
7	Boehringer Ingelheim Investigational Site	Joensuu		Finland	FI-80100
8	Boehringer Ingelheim Investigational Site	Kokkola		Finland	FI-67200
9	Boehringer Ingelheim Investigational Site	Turku		Finland	FI-20100
10	Boehringer Ingelheim Investigational Site	Turku		Finland	FI-20520
11	ALTI	Angers		France	49000
12	ALTI	Angers		France	49100
13	Hopital Avicenne	Bobigny		France	93000
14	Mg Recherches	Paris		France	75015
15	Boehringer Ingelheim Investigational Site	Ellefeld		Germany	08236
16	Boehringer Ingelheim Investigational Site	Florsheim		Germany	65439
17	Boehringer Ingelheim Investigational Site	Frankfurt/Main		Germany	60323
18	Boehringer Ingelheim Investigational Site	Haag		Germany	83527
19	Boehringer Ingelheim Investigational Site	Ingelheim		Germany	55218
20	Boehringer Ingelheim Investigational Site	Nurnberg		Germany	90402
21	Boehringer Ingelheim Investigational Site	Rodgau-Dudenhofen		Germany	63110
22	Boehringer Ingelheim Investigational Site	Unterschneidheim		Germany	73485
23	Boehringer Ingelheim Investigational Site	Hong Kong		Hong Kong
24	Boehringer Ingelheim Investigational Site	Birr		Ireland
25	Boehringer Ingelheim Investigational Site	Carrigallen		Ireland
26	Boehringer Ingelheim Investigational Site	Dublin 18		Ireland
27	Boehringer Ingelheim Investigational Site	Dublin 24		Ireland
28	Boehringer Ingelheim Investigational Site	Dublin 9		Ireland
29	Boehringer Ingelheim Investigational Site	Enniscorthy,		Ireland
30	Boehringer Ingelheim Investigational Site	Gorey		Ireland
31	Boehringer Ingelheim Investigational Site	Mallow		Ireland
32	Boehringer Ingelheim Investigational Site	New Ross		Ireland
33	Boehringer Ingelheim Investigational Site	Toomevara		Ireland
34	Ospedale Arnaboldi	Broni (PV)		Italy	27043
35	Azienda Ospedaliera Universita di Ferrara	Ferrara		Italy	44100
36	IRCCS San Raffaele	Roma		Italy	00163
37	Ospedale Civile	Vittorio Veneto (TV)		Italy	31029
38	Boehringer Ingelheim Investigational Site	Incheon		Korea, Republic of	405760
39	Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of	134701
40	Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of	152703
41	Boehringer Ingelheim Investigational Site	Kuching, Sarawak		Malaysia	93586
42	Boehringer Ingelheim Investigational Site	Bennebroek		Netherlands	2121 BB
43	Boehringer Ingelheim Investigational Site	Ewijk		Netherlands	6644 CL
44	Boehringer Ingelheim Investigational Site	Helmond		Netherlands	5704 CM
45	Boehringer Ingelheim Investigational Site	Hoogwoud		Netherlands	1817 BG
46	Boehringer Ingelheim Investigational Site	Nijverdal		Netherlands	7442 LS
47	Boehringer Ingelheim Investigational Site	Oude Pekela		Netherlands	9665 AR
48	Boehringer Ingelheim Investigational Site	Oude Pekela		Netherlands	9665 BJ
49	Boehringer Ingelheim Investigational Site	Rijswijk		Netherlands	2281 AK
50	Boehringer Ingelheim Investigational Site	Roelofarendsveen		Netherlands	2371 RB
51	Boehringer Ingelheim Investigational Site	Rotterdam		Netherlands	3082 DC
52	Boehringer Ingelheim Investigational Site	Elverum		Norway	N-2408
53	Boehringer Ingelheim Investigational Site	Moelv		Norway	N-2391
54	Boehringer Ingelheim Investigational Site	Oslo		Norway	N-0369
55	Boehringer Ingelheim Investigational Site	Skedsmokorset		Norway	N-2020
56	Boehringer Ingelheim Investigational Site	Tolvsr?d		Norway	N-3153
57	Boehringer Ingelheim Investigational Site	Bellville		South Africa	7531
58	Boehringer Ingelheim Investigational Site	Durban		South Africa	4091
59	Boehringer Ingelheim Investigational Site	Johannesburg		South Africa	2001
60	Boehringer Ingelheim Investigational Site	Johannesburg		South Africa	2013
61	Boehringer Ingelheim Investigational Site	Lenasia South		South Africa	2033
62	Boehringer Ingelheim Investigational Site	Lenasia		South Africa	2033
63	Boehringer Ingelheim Investigational Site	Midrand		South Africa	1685
64	Boehringer Ingelheim Investigational Site	Pretoria		South Africa	0038
65	Hospital Municipal de Badalona	Badalona / Barcelona		Spain	08911
66	Hospital de Galdakao	Galdakao / Vizcaya		Spain	48680
67	Hospital Gral. Jerez de la Frontera	Jerez De La Frontera / Cadiz		Spain	11407
68	C.A.P. Mosen Cinto Verdaguer	L'Hospitalet De Llobregat / Barcelona		Spain	08902
69	Hospital Universitario Gregorio Mara?on	Madrid		Spain	28007
70	C.A.P. Ronda Cerdanya	Mataro (Barcelona)		Spain	08303
71	Hospital General de Mostoles - Medicina Interna	Mostoles / Madrid		Spain	28935
72	Hospital del Conxo	Santiago de Compostela		Spain	15706
73	Boehringer Ingelheim Investigational Site	Eksjo		Sweden	575 36
74	Boehringer Ingelheim Investigational Site	Karlstad		Sweden	651 85
75	Boehringer Ingelheim Investigational Site	Karlstad		Sweden	652 24
76	Boehringer Ingelheim Investigational Site	Uddevalla		Sweden	451 40
77	Boehringer Ingelheim Investigational Site	Uppsala		Sweden	751 25
78	Boehringer Ingelheim Investigational Site	Basel		Switzerland	4031
79	Boehringer Ingelheim Investigational Site	Basel		Switzerland	4051
80	Boehringer Ingelheim Investigational Site	Basel		Switzerland	4052
81	Boehringer Ingelheim Investigational Site	Bellinzona		Switzerland	6500
82	Boehringer Ingelheim Investigational Site	St. Imier		Switzerland	2610
83	Boehringer Ingelheim Investigational Site	Vezia		Switzerland	6943
84	Boehringer Ingelheim Investigational Site	Taipei		Taiwan	104
85	Boehringer Ingelheim Investigational Site	Taipei		Taiwan	112
86	Boehringer Ingelheim Investigational Site	Taipei		Taiwan

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim Study Coordinator, BIL UK / Ireland

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info
• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00239369
• Other Study ID Numbers: 502.480
• First Posted: Oct 17, 2005
• Last Update Posted: Dec 28, 2017
• Last Verified: Dec 1, 2017

• Additional relevant MeSH terms: Hypertension; Telmisartan; Hydrochlorothiazide

Study Results

No Results Posted as of Dec 28, 2017