Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Add-on to Micamlo BP Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01975246
First received: October 29, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.


Condition Intervention Phase
Hypertension
Drug: Telmisartan + amlodipine
Drug: hydrochlorothiazide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Amlodipine 5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Amlodipine 5 mg

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
  • The proportion of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]

Enrollment: 309
Study Start Date: November 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telmisartan+amlodipine+HCTZ
telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet
Drug: Telmisartan + amlodipine
FDC tablet
Drug: hydrochlorothiazide
tablet
Active Comparator: Telmisartan+amlodipine
telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet
Drug: Telmisartan + amlodipine
FDC tablet
Drug: Placebo
placebo matching hydrochlorothiazide tablet

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean seated systolic blood pressure (SBP) must be =<200 mmHg
  • Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
  • Age 20 years or older

Exclusion criteria:

  • Patients with known or suspected secondary hypertension
  • Patients with clinically relevant cardiac arrhythmia
  • Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
  • Patients with recent cardiovascular events
  • Patients with recent stroke events
  • Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
  • Patients with hepatic and/or renal dysfunction
  • Pre-menopausal women who are nursing or pregnant
  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: NCT01975246

Locations
Japan
1348.1.015 Boehringer Ingelheim Investigational Site
Atsubetsu-ku,Sapporo,Hokkaido, Japan
1348.1.006 Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo, Japan
1348.1.002 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1348.1.005 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1348.1.031 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1348.1.030 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1348.1.033 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1348.1.016 Boehringer Ingelheim Investigational Site
Chuo-ku,Sapporo,Hokkaido, Japan
1348.1.021 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.1.024 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo, Japan
1348.1.028 Boehringer Ingelheim Investigational Site
Itoshima, Fukuoka, Japan
1348.1.027 Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo, Japan
1348.1.001 Boehringer Ingelheim Investigational Site
Kishiwada, Osaka, Japan
1348.1.009 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka, Japan
1348.1.029 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka, Japan
1348.1.014 Boehringer Ingelheim Investigational Site
Kiyose,Tokyo, Japan
1348.1.003 Boehringer Ingelheim Investigational Site
Koto-ku, Tokyo, Japan
1348.1.022 Boehringer Ingelheim Investigational Site
Mihama-ku, Chiba, Chiba, Japan
1348.1.004 Boehringer Ingelheim Investigational Site
Miyagino-ku, Sendai, Miyagi, Japan
1348.1.017 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki, Japan
1348.1.013 Boehringer Ingelheim Investigational Site
Naka-ku,Yokohama,Kanagawa, Japan
1348.1.018 Boehringer Ingelheim Investigational Site
Nishi-ku, Fukuoka, Fukuoka, Japan
1348.1.007 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa, Japan
1348.1.020 Boehringer Ingelheim Investigational Site
Sakaide, Kagawa, Japan
1348.1.025 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1348.1.026 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1348.1.008 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
1348.1.032 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
1348.1.019 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa, Japan
1348.1.023 Boehringer Ingelheim Investigational Site
Toshima-ku, Tokyo, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01975246     History of Changes
Other Study ID Numbers: 1348.1
Study First Received: October 29, 2013
Last Updated: July 23, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Hydrochlorothiazide
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014