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A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00240448
Collaborator
(none)
1,109
Enrollment
100
Locations
11.1
Patients Per Site

Study Details

Study Description

Brief Summary

The primary objective of this study is to compare the effectiveness of telmisartan 80 mg/hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg/hydrochlorothiazide 25 mg [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.

Condition or Disease Intervention/Treatment Phase
  • Drug: telmisartan 80 mg/hydrochlorothiazide 25 mg
  • Drug: valsartan 160 mg/hydrochlorothiazide 25 mg
  • Drug: placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1109 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Double-dummy, Placebo-controlled, Forced-titration, Comparison of MICARDIS® HCT (Telmisartan 80 mg / Hydrochlorothiazide 25 mg) Versus DIOVAN® HCT (Valsartan 160 mg / Hydrochlorothiazide 25 mg) Using Seated Trough Cuff Blood Pressure in Patients With Stage 1 and Stage 2 Hypertension
Study Start Date :
Sep 1, 2003
Actual Primary Completion Date :
Jun 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period []

Secondary Outcome Measures

  1. Percentage of responders based on change from baseline in cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period []

Eligibility Criteria

Criteria

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

Inclusion criteria

  1. Ability to provide written informed consent.

  2. Age 18 years or older.

  3. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion).

  4. Seated cuff DBP of 95 mmHg at Visit 2 (baseline).

Exclusion criteria

  1. Pre-menopausal women (last menstruation 1 year prior to start of run-in period) who:

  • Are not surgically sterile and/or

  • Are nursing or pregnant

  • Are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device (IUD).

  1. Known or suspected secondary hypertension.

  2. Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit prior to randomization.

  3. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

  • SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or

  • Serum creatinine > 3.0 mg/dL or creatinine clearance < 0.6 ml/sec.

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

  2. Clinically relevant hypokalemia or hyperkalemia.

  3. Uncorrected volume depletion.

  4. Uncorrected sodium depletion.

  5. Primary aldosteronism.

  6. Hereditary fructose intolerance.

  7. Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency.

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

  9. History of drug or alcohol dependency within six months prior to start of run-in period.

  10. Chronic administration of any medications known to affect blood pressure, etc.

  11. Any investigational drug therapy within one month of start of run-in period.

  12. known hypersensitivity to any component of the formulation study drugs (telmisartan, valsartan, HCT).

  13. Contra-indication to a placebo run-in period (e.g. stroke within the past six months, MI, cardia surgery, PTCA or angina within the past three months prior to the start of run-in period.

  14. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan, valsartan, or HCT.

  15. Night shift workers.

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

  17. NYHA functional class CHF III-IV.

  18. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.

  19. Patients whose diabetes has been unstable and uncontrolled for at least the past 3 months as defined by a HbA1c >/= 10%.

  20. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCT).

  21. History of non-compliance with prescribed medication or protocol procedures.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boehringer Ingelheim Investigational Site Birmingham Alabama United States
2 Boehringer Ingelheim Investigational Site Huntsville Alabama United States
3 Boehringer Ingelheim Investigational Site Mobile Alabama United States
4 Boehringer Ingelheim Investigational Site Sctoosdale Arizona United States
5 Boehringer Ingelheim Investigational Site Tucson Arizona United States
6 Boehringer Ingelheim Investigational Site Bentonville Arkansas United States
7 Boehringer Ingelheim Investigational Site Carlisle Arkansas United States
8 Boehringer Ingelheim Investigational Site Hot Springs Arkansas United States
9 Boehringer Ingelheim Investigational Site Concord California United States
10 Memorial Research Medical Clinic Long Beach California United States
11 Boehringer Ingelheim Investigational Site Orange California United States
12 Boehringer Ingelheim Investigational Site Riverside California United States
13 Clinical Trials Research Roseville California United States
14 Boehringer Ingelheim Investigational Site Sacramento California United States
15 Boehringer Ingelheim Investigational Site San Leandro California United States
16 Boehringer Ingelheim Investigational Site Santa Ana California United States
17 Boehringer Ingelheim Investigational Site Sepulveda California United States
18 Boehringer Ingelheim Investigational Site Spring Valley California United States
19 Boehringer Ingelheim Investigational Site Torrance California United States
20 Boehringer Ingelheim Investigational Site Boulder Colorado United States
21 Boehringer Ingelheim Investigational Site Bridgeport Connecticut United States
22 Boehringer Ingelheim Investigational Site Farmington Connecticut United States
23 Clinical Research Consultants, Inc. Trumbull Connecticut United States
24 Boehringer Ingelheim Investigational Site Waterbury Connecticut United States
25 Boehringer Ingelheim Investigational Site Newark Delaware United States
26 Boehringer Ingelheim Investigational Site Coral Gables Florida United States
27 Boehringer Ingelheim Investigational Site Ft. Lauderdale Florida United States
28 Boehringer Ingelheim Investigational Site Ft. Myers Florida United States
29 Boehringer Ingelheim Investigational Site Holiday Florida United States
30 Boehringer Ingelheim Investigational Site Hollywood Florida United States
31 Christopher Chappel, MD Kissimmee Florida United States
32 Boehringer Ingelheim Investigational Site Largo Florida United States
33 Orlando Clinical Research Center Orlando Florida United States
34 Boehringer Ingelheim Investigational Site Palm Harbor Florida United States
35 Boehringer Ingelheim Investigational Site Panama City Florida United States
36 Attention: Larry I. Gilderman, D.O. Pembroke Pines Florida United States
37 Boehringer Ingelheim Investigational Site Pembroke Pines Florida United States
38 Boehringer Ingelheim Investigational Site Atlanta Georgia United States
39 Grady Memorial Hospital Atlanta Georgia United States
40 Boehringer Ingelheim Investigational Site Conyers Georgia United States
41 Treasure Valley Cardiology Boise Idaho United States
42 Boehringer Ingelheim Investigational Site Chicago Illinois United States
43 Cedar-Crosse Research Center Chicago Illinois United States
44 Herron Medical Center, Ltd. Chicago Illinois United States
45 Boehringer Ingelheim Investigational Site Orland Park Illinois United States
46 N Touch Research Peoria Illinois United States
47 Midwest Institute for Clinical Research Inc. Indianapolis Indiana United States
48 Boehringer Ingelheim Investigational Site Waterloo Iowa United States
49 Boehringer Ingelheim Investigational Site Shawnee Kansas United States
50 Boehringer Ingelheim Investigational Site Wichita Kansas United States
51 Boehringer Ingelheim Investigational Site Louisville Kentucky United States
52 Attn:William Smith New Orleans Louisiana United States
53 Boehringer Ingelheim Investigational Site Baltimore Maryland United States
54 Boehringer Ingelheim Investigational Site Brookline Massachusetts United States
55 Waltham Hospital Waltham Massachusetts United States
56 Boehringer Ingelheim Investigational Site Troy Michigan United States
57 Boehringer Ingelheim Investigational Site Brooklyn Center Minnesota United States
58 Radiant Research Edina Minnesota United States
59 Boehringer Ingelheim Investigational Site Jackson Mississippi United States
60 Boehringer Ingelheim Investigational Site Kansas City Missouri United States
61 Department of Medicine Camden New Jersey United States
62 Boehringer Ingelheim Investigational Site Cherry Hill New Jersey United States
63 Boehringer Ingelheim Investigational Site Bronx New York United States
64 Boehringer Ingelheim Investigational Site Kingston New York United States
65 Northport VAMC - Medical Service (111) Northport New York United States
66 Boehringer Ingelheim Investigational Site Rochester New York United States
67 Boehringer Ingelheim Investigational Site Scarsdale New York United States
68 Boehringer Ingelheim Investigational Site Burlington North Carolina United States
69 Boehringer Ingelheim Investigational Site Cary North Carolina United States
70 Boehringer Ingelheim Investigational Site Durham North Carolina United States
71 Boehringer Ingelheim Investigational Site Raleigh North Carolina United States
72 Boehringer Ingelheim Investigational Site Stateville North Carolina United States
73 Boehringer Ingelheim Investigational Site Winston-Salem North Carolina United States
74 Boehringer Ingelheim Investigational Site Cincinnati Ohio United States
75 Radiant Reseach Cincinnati Ohio United States
76 Boehringer Ingelheim Investigational Site Columbus Ohio United States
77 Ohio State University Columbus Ohio United States
78 Radiant Research Columbus Ohio United States
79 Boehringer Ingelheim Investigational Site Mansfield Ohio United States
80 Boehringer Ingelheim Investigational Site Mogadore Ohio United States
81 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma United States
82 Boehringer Ingelheim Investigational Site Tulsa Oklahoma United States
83 Bock Clinical Research Collegeville Pennsylvania United States
84 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania United States
85 Boehringer Ingelheim Investigational Site Pottstown Pennsylvania United States
86 Boehringer Ingelheim Investigational Site East Providence Rhode Island United States
87 Boehringer Ingelheim Investigational Site Greer South Carolina United States
88 Boehringer Ingelheim Investigational Site Nashville Tennessee United States
89 Boehringer Ingelheim Investigational Site Austin Texas United States
90 Boehringer Ingelheim Investigational Site Carrollton Texas United States
91 Boehringer Ingelheim Investigational Site Dallas Texas United States
92 Boehringer Ingelheim Investigational Site Houston Texas United States
93 Boehringer Ingelheim Investigational Site McKinney Texas United States
94 Boehringer Ingelheim Investigational Site San Antonio Texas United States
95 Boehringer Ingelheim Investigational Site Salt Lake City Utah United States
96 Clinical Research Center of N. VA Falls Church Virginia United States
97 Boehringer Ingelheim Investigational Site Lacey Washington United States
98 Boehringer Ingelheim Investigational Site Lakewood Washington United States
99 Boehringer Ingelheim Investigational Site Madison Wisconsin United States
100 Boehringer Ingelheim Investigational Site Milwaukee Wisconsin United States

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00240448
Other Study ID Numbers:
  • 502.421
First Posted:
Oct 18, 2005
Last Update Posted:
Nov 5, 2013
Last Verified:
Nov 1, 2013
Additional relevant MeSH terms:
Hypertension
Valsartan
Hydrochlorothiazide
Telmisartan

Study Results

No Results Posted as of Nov 5, 2013