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NCT00926289 Clinical Trial

Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

Hypertension Clinical Trial

Official title:
A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00926289
Other study ID # 502.550
Secondary ID 2008-007711-32
Status Completed
Phase Phase 4
First received June 22, 2009
Last updated June 17, 2014
Start date June 2009

Study information
Verified date December 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Bulgarian Drug AgencyChina: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Georgia: Ministry of HealthKorea: Food and Drug AdministrationRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).

Recruitment information / eligibility
Status Completed
Enrollment 894
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation;

2. Age 18 years or older;

3. Patients with grade 2 or grade 3 hypertension as defined SBP>=160 mmHg and DBP>=100 mmHg at randomization

4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)

Exclusion criteria:

1. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial. The only acceptable methods of birth control are: Intra-Uterine Device (IUD), Oral contraceptives, Implantable or injectable contraceptives, Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.

2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.

3. Known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)

4. Mean in-clinic seated cuff SBP>= 200 mmHg and/or DBP >=120 mmHg

5. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 umol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.

6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney

7. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L, may be rechecked for suspected error in result)

8. Uncorrected sodium or volume depletion

9. Primary aldosteronism.

10. Hereditary fructose intolerance

11. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency

12. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.3)

13. Contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run in period)

14. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator

15. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

16. Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an Glycosylated Hemoglobin >=10%

17. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists

18. History of drug or alcohol dependency within 6 months prior to signing the informed consent form

19. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol

20. Any investigational drug therapy within 1 month of signing the informed consent

21. Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)

22. History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in)

23. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Telmisartan
Telmisartan 80mg
• Telmisartan
Telmisartan 80mg
• Hydrochlorothiazide
Hydrochlorothiazide25mg

Locations
Country Name City State
Bulgaria 502.550.35901 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 502.550.35902 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 502.550.35903 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 502.550.35904 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 502.550.35905 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 502.550.35908 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 502.550.35909 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 502.550.35910 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 502.550.35911 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 502.550.35906 Boehringer Ingelheim Investigational Site Stara Zagora
China 502.550.86004 Boehringer Ingelheim Investigational Site Changsha
China 502.550.86003 Boehringer Ingelheim Investigational Site Guangzhou, Guangdong Province
China 502.550.86008 Boehringer Ingelheim Investigational Site QingDao
China 502.550.86001 Boehringer Ingelheim Investigational Site Shanghai
China 502.550.86002 Boehringer Ingelheim Investigational Site Shanghai
China 502.550.86009 Boehringer Ingelheim Investigational Site Shenyang
China 502.550.86007 Boehringer Ingelheim Investigational Site Tianjin
China 502.550.86010 Boehringer Ingelheim Investigational Site Zhengzhou
France 502.550.3302D Boehringer Ingelheim Investigational Site Aigrefeuille S/Maine
France 502.550.3305I Boehringer Ingelheim Investigational Site Aix-en-Provence
France 502.550.3305G Boehringer Ingelheim Investigational Site Aubagne
France 502.550.3301H Boehringer Ingelheim Investigational Site Briollay
France 502.550.3301K Boehringer Ingelheim Investigational Site Cholet
France 502.550.3302I Boehringer Ingelheim Investigational Site Corsept
France 502.550.3302C Boehringer Ingelheim Investigational Site Donges
France 502.550.3302B Boehringer Ingelheim Investigational Site La Montagne
France 502.550.3306A Boehringer Ingelheim Investigational Site Louvigné de Bais
France 502.550.3303A Boehringer Ingelheim Investigational Site Marseille
France 502.550.3303D Boehringer Ingelheim Investigational Site Marseille
France 502.550.3303F Boehringer Ingelheim Investigational Site Marseille
France 502.550.3304A Boehringer Ingelheim Investigational Site Marseille
France 502.550.3304D Boehringer Ingelheim Investigational Site Marseille
France 502.550.3304F Boehringer Ingelheim Investigational Site Marseille
France 502.550.3304J Boehringer Ingelheim Investigational Site Marseille
France 502.550.3305A Boehringer Ingelheim Investigational Site Marseille
France 502.550.3301A Boehringer Ingelheim Investigational Site Murs Erigne
France 502.550.3301I Boehringer Ingelheim Investigational Site Murs-Erigne
France 502.550.3302A Boehringer Ingelheim Investigational Site Nantes
France 502.550.3302E Boehringer Ingelheim Investigational Site Nantes
France 502.550.3301E Boehringer Ingelheim Investigational Site Parcay-les-Pins
France 502.550.3303C Boehringer Ingelheim Investigational Site Roquevaire
France 502.550.3301F Boehringer Ingelheim Investigational Site Segre
France 502.550.3302G Boehringer Ingelheim Investigational Site St Aubin les Châteaux
France 502.550.3306F Boehringer Ingelheim Investigational Site St Jouan des Guerets
France 502.550.3307A Boehringer Ingelheim Investigational Site Thouars
France 502.550.3301J Boehringer Ingelheim Investigational Site Vihiers
Georgia 502.550.99501 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 502.550.99502 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 502.550.99503 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 502.550.99504 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 502.550.99505 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 502.550.99506 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 502.550.99507 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 502.550.99508 Boehringer Ingelheim Investigational Site Tbilisi
Korea, Republic of 502.550.82008 Boehringer Ingelheim Investigational Site Cheonan
Korea, Republic of 502.550.82009 Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of 502.550.82001 Boehringer Ingelheim Investigational Site Goyang
Korea, Republic of 502.550.82003 Boehringer Ingelheim Investigational Site Gwangju
Korea, Republic of 502.550.82002 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 502.550.82005 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 502.550.82006 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 502.550.82007 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 502.550.82011 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 502.550.82012 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 502.550.82013 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 502.550.82004 Boehringer Ingelheim Investigational Site Suwon
Korea, Republic of 502.550.82010 Boehringer Ingelheim Investigational Site Wonju
Romania 502.550.40002 Boehringer Ingelheim Investigational Site Baia Mare Maramures
Romania 502.550.40003 Boehringer Ingelheim Investigational Site Braila
Romania 502.550.40001 Boehringer Ingelheim Investigational Site Bucharest
Romania 502.550.40010 Boehringer Ingelheim Investigational Site Bucharest
Romania 502.550.40012 Boehringer Ingelheim Investigational Site Bucharest
Romania 502.550.40009 Boehringer Ingelheim Investigational Site Cluj Napoca
Romania 502.550.40011 Boehringer Ingelheim Investigational Site Cluj Napoca
Romania 502.550.40006 Boehringer Ingelheim Investigational Site Iasi
Romania 502.550.40004 Boehringer Ingelheim Investigational Site Oradea
Romania 502.550.40005 Boehringer Ingelheim Investigational Site Sibiu
Romania 502.550.40008 Boehringer Ingelheim Investigational Site Tg. Mures
Russian Federation 502.550.07001 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 502.550.07002 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 502.550.07003 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 502.550.07004 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 502.550.07005 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 502.550.07006 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 502.550.07007 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 502.550.07008 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 502.550.07009 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 502.550.07010 Boehringer Ingelheim Investigational Site St.Petersburg
United States 502.550.01004 Boehringer Ingelheim Investigational Site Arlington Virginia
United States 502.550.01008 Boehringer Ingelheim Investigational Site Athens Alabama
United States 502.550.01016 Boehringer Ingelheim Investigational Site Charlotte North Carolina
United States 502.550.01005 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 502.550.01001 Boehringer Ingelheim Investigational Site Cleveland Ohio
United States 502.550.01003 Boehringer Ingelheim Investigational Site Colorado Springs Colorado
United States 502.550.01014 Boehringer Ingelheim Investigational Site Fort Lauderdale Florida
United States 502.550.01007 Boehringer Ingelheim Investigational Site Greensboro North Carolina
United States 502.550.01017 Boehringer Ingelheim Investigational Site Houston Texas
United States 502.550.01020 Boehringer Ingelheim Investigational Site Houston Texas
United States 502.550.01015 Boehringer Ingelheim Investigational Site Lomita California
United States 502.550.01002 Boehringer Ingelheim Investigational Site Louisville Kentucky
United States 502.550.01019 Boehringer Ingelheim Investigational Site Mobile Alabama
United States 502.550.01011 Boehringer Ingelheim Investigational Site New Iberia Louisiana
United States 502.550.01009 Boehringer Ingelheim Investigational Site New Orleans Louisiana
United States 502.550.01018 Boehringer Ingelheim Investigational Site Olive Branch Mississippi
United States 502.550.01012 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 502.550.01006 Boehringer Ingelheim Investigational Site St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  France,  Georgia,  Korea, Republic of,  Romania,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 The SBP value at baseline was subtracted from the SBP value at Week 7. Baseline and Week 7 No
Secondary Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 The SBP value at baseline was subtracted from the SBP value at Week 5. Baseline and Week 5 No
Secondary Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 The SBP value at baseline was subtracted from the SBP value at Week 3. Baseline and Week 3 No
Secondary Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 The DBP value at baseline was subtracted from the DBP value at Week 7. Baseline and Week 7 No
Secondary Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 SBP control is defined as SBP < 140 mmHg. Week 7 timepoint No
Secondary Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5 SBP control is defined as SBP < 140 mmHg Week 5 timepoint No
Secondary Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3 SBP control is defined as SBP < 140 mmHg Week 3 timepoint No
Secondary Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7 DBP control is defined as DBP<90 mmHg Week 7 timepoint No
Secondary Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5 DBP control is defined as DBP<90 mmHg Week 5 timepoint No
Secondary Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3 DBP control is defined as DBP<90 mmHg Week 3 timepoint No
Secondary Number of Patients With Blood Pressure (BP) Control at Week 7 BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP Week 7 timepoint No
Secondary Number of Patients With BP Control at Week 7 BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP Week 7 timepoint No
Secondary Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7 SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg Week 7 timepoint No
Secondary Number of Participants With DBP Response at Week 7 DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg Week 7 timepoint No
Secondary BP Categories at Week 7 BP categories comprise:
BP optimal (SBP <120 mmHg and DBP <80 mmHg)
BP normal (SBP <130 mmHg and DBP <85 mmHg but not 'optimal')
BP high normal (SBP <140 mmHg and DBP <90 mmHg but not 'normal')
Grade 1 hypertension (SBP <160 mmHg and DBP <100 mmHg but not 'high normal')
Grade 2 hypertension (SBP <180 mmHg and DBP <110 mmHg but not 'Grade 1 hypertension')
Grade 3 hypertension (SBP =180 mmHg or DBP =110 mmHg)		 Week 7 timepoint No
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