Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine

NCT01911780 | Completed Phase 3 Results

• 1 other identifier: 1348.2
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 17

Brief Summary

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+ hydrochlorothiazide 12.5 mg (T80/H12.5 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+ hydrochlorothiazide 12.5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg. In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period. In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.

  Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.

  baseline and 8 weeks

Secondary Outcomes (5)

• Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.

  baseline and 8 weeks

• The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.

  Double-blind and 8 weeks

• The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.

  Reference baseline (week 0) and week 60 (end of extension period)

• Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.

  Reference baseline (week 0) and week 60 (end of extension period)

• Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.

  Reference baseline (week 0) and week 60 (end of extension period)

Study Arms (2)

telmisartan + HCTZ + amlodipine

EXPERIMENTAL

telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)

Drug: telmisartan + HCTZ; Drug: amlodipine

telmisartan + HCTZ + placebo

ACTIVE COMPARATOR

telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)

Drug: placebo; Drug: telmisartan + HCTZ

Interventions

placebo DRUG

placebo matching amlodipine capsule

telmisartan + HCTZ + placebo

telmisartan + HCTZ DRUG

FDC tablet

telmisartan + HCTZ + placebo

amlodipine DRUG

capsule

telmisartan + HCTZ + amlodipine

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (17)

1348.2.020 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

1348.2.008 Boehringer Ingelheim Investigational Site

Chuo-ku, Fukuoka, Fukuoka, Japan

Location

1348.2.018 Boehringer Ingelheim Investigational Site

Chuo-ku,Kobe, Hyogo, Japan

Location

1348.2.006 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, Japan

Location

1348.2.013 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, Japan

Location

1348.2.021 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, Japan

Location

1348.2.012 Boehringer Ingelheim Investigational Site

Hirakata, Osaka, Japan

Location

1348.2.011 Boehringer Ingelheim Investigational Site

Kasaoka, Okayama, Japan

Location

1348.2.001 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, Japan

Location

1348.2.019 Boehringer Ingelheim Investigational Site

Kita-ku, Osaka-shi, Osaka, Japan

Location

1348.2.014 Boehringer Ingelheim Investigational Site

Kiyota-ku, Sapporo-shi, Hokkaido, Japan

Location

1348.2.002 Boehringer Ingelheim Investigational Site

Kumamoto, Kumamoto, Japan

Location

1348.2.007 Boehringer Ingelheim Investigational Site

Nakano-ku,Tokyo, Japan

Location

1348.2.009 Boehringer Ingelheim Investigational Site

Nishi-ku, Fukuoka, Fukuoka, Japan

Location

1348.2.005 Boehringer Ingelheim Investigational Site

Takatsuki, Osaka, Japan

Location

1348.2.016 Boehringer Ingelheim Investigational Site

Uji, Kyoto, Japan

Location

1348.2.010 Boehringer Ingelheim Investigational Site

Yoshikawa, Saitama, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 30, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 28, 2016
• Results First Posted: March 28, 2016

Record last verified: 2016-02

Locations

JP (17)