Add-on to Micamlo BP Trial

NCT01975246 | Completed Phase 3 Results

• 1 other identifier: 1348.1
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 30

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+ 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.

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 after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.

  baseline and week 8

Secondary Outcomes (2)

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

  baseline and week 8

• 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

  baseline and week 8

Study Arms (2)

Telmisartan+amlodipine+HCTZ

EXPERIMENTAL

telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet

Drug: Telmisartan + amlodipine; Drug: hydrochlorothiazide

Telmisartan+amlodipine

ACTIVE COMPARATOR

telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet

Drug: Telmisartan + amlodipine; Drug: Placebo

Interventions

Telmisartan + amlodipine DRUG

FDC tablet

Telmisartan+amlodipine+HCTZ

hydrochlorothiazide DRUG

tablet

Telmisartan+amlodipine+HCTZ

Placebo DRUG

placebo matching hydrochlorothiazide tablet

Telmisartan+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 (30)

1348.1.015 Boehringer Ingelheim Investigational Site

Atsubetsu-ku,Sapporo,Hokkaido, Japan

Location

1348.1.006 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

1348.1.002 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

1348.1.005 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

1348.1.031 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

1348.1.030 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1348.1.033 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1348.1.016 Boehringer Ingelheim Investigational Site

Chuo-ku,Sapporo,Hokkaido, Japan

Location

1348.1.021 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, Japan

Location

1348.1.024 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, Japan

Location

1348.1.028 Boehringer Ingelheim Investigational Site

Itoshima, Fukuoka, Japan

Location

1348.1.027 Boehringer Ingelheim Investigational Site

Katsushika-ku, Tokyo, Japan

Location

1348.1.001 Boehringer Ingelheim Investigational Site

Kishiwada, Osaka, Japan

Location

1348.1.009 Boehringer Ingelheim Investigational Site

Kita-ku, Osaka, Japan

Location

1348.1.029 Boehringer Ingelheim Investigational Site

Kita-ku, Osaka, Japan

Location

1348.1.014 Boehringer Ingelheim Investigational Site

Kiyose,Tokyo, Japan

Location

1348.1.003 Boehringer Ingelheim Investigational Site

Koto-ku, Tokyo, Japan

Location

1348.1.022 Boehringer Ingelheim Investigational Site

Mihama-ku, Chiba, Chiba, Japan

Location

1348.1.004 Boehringer Ingelheim Investigational Site

Miyagino-ku, Sendai, Miyagi, Japan

Location

1348.1.017 Boehringer Ingelheim Investigational Site

Moriya, Ibaraki, Japan

Location

1348.1.013 Boehringer Ingelheim Investigational Site

Naka-ku,Yokohama,Kanagawa, Japan

Location

1348.1.018 Boehringer Ingelheim Investigational Site

Nishi-ku, Fukuoka, Fukuoka, Japan

Location

1348.1.007 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, Japan

Location

1348.1.020 Boehringer Ingelheim Investigational Site

Sakaide, Kagawa, Japan

Location

1348.1.025 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1348.1.026 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1348.1.008 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1348.1.032 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1348.1.019 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, Japan

Location

1348.1.023 Boehringer Ingelheim Investigational Site

Toshima-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan amlodipine combination; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: October 29, 2013
• First Posted: November 4, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 29, 2016
• Results First Posted: November 29, 2016

Record last verified: 2016-10

Locations

JP (30)