Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

May 16, 2014 updated by: Boehringer Ingelheim

An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
858

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Bourgas, Bulgaria
        • 1235.20.001 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.20.002 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.20.003 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.20.005 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.20.006 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.20.007 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.20.008 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.20.009 Boehringer Ingelheim Investigational Site
      • Stara Zagora, Bulgaria
        • 1235.20.004 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Benatky nad Jizerou, Czech Republic
        • 1235.20.052 Boehringer Ingelheim Investigational Site
      • Cesky Krumlov, Czech Republic
        • 1235.20.059 Boehringer Ingelheim Investigational Site
      • Plzen, Czech Republic
        • 1235.20.051 Boehringer Ingelheim Investigational Site
      • Praha 5, Czech Republic
        • 1235.20.053 Boehringer Ingelheim Investigational Site
      • Pribram, Czech Republic
        • 1235.20.054 Boehringer Ingelheim Investigational Site
      • Slany, Czech Republic
        • 1235.20.055 Boehringer Ingelheim Investigational Site
      • Strakonice, Czech Republic
        • 1235.20.057 Boehringer Ingelheim Investigational Site
      • Tabor, Czech Republic
        • 1235.20.058 Boehringer Ingelheim Investigational Site
  • France
      • Albens, France
        • 1235.20.101A Boehringer Ingelheim Investigational Site
      • Arles, France
        • 1235.20.102F Boehringer Ingelheim Investigational Site
      • Beziers, France
        • 1235.20.103A Boehringer Ingelheim Investigational Site
      • Beziers, France
        • 1235.20.103C Boehringer Ingelheim Investigational Site
      • Beziers, France
        • 1235.20.103F Boehringer Ingelheim Investigational Site
      • Bourg des cptes, France
        • 1235.20.106A Boehringer Ingelheim Investigational Site
      • Brive, France
        • 1235.20.109B Boehringer Ingelheim Investigational Site
      • Carbonne, France
        • 1235.20.108E Boehringer Ingelheim Investigational Site
      • Chambery, France
        • 1235.20.101D Boehringer Ingelheim Investigational Site
      • Cournonterral, France
        • 1235.20.103E Boehringer Ingelheim Investigational Site
      • Cugnaux, France
        • 1235.20.108C Boehringer Ingelheim Investigational Site
      • Etrelles, France
        • 1235.20.106D Boehringer Ingelheim Investigational Site
      • Fenouillet, France
        • 1235.20.108F Boehringer Ingelheim Investigational Site
      • Gemenos, France
        • 1235.20.102A Boehringer Ingelheim Investigational Site
      • Gemenos, France
        • 1235.20.102C Boehringer Ingelheim Investigational Site
      • Gresy Sur Aix, France
        • 1235.20.101C Boehringer Ingelheim Investigational Site
      • Labarthe Sur Leze, France
        • 1235.20.108A Boehringer Ingelheim Investigational Site
      • Labarthe sur Leze, France
        • 1235.20.108B Boehringer Ingelheim Investigational Site
      • Louvigne De bais, France
        • 1235.20.106F Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1235.20.102E Boehringer Ingelheim Investigational Site
      • Mordelles, France
        • 1235.20.106B Boehringer Ingelheim Investigational Site
      • Ortez, France
        • 1235.20.107A Boehringer Ingelheim Investigational Site
      • Orthez, France
        • 1235.20.107B Boehringer Ingelheim Investigational Site
      • Orthez, France
        • 1235.20.107E Boehringer Ingelheim Investigational Site
      • Orthez, France
        • 1235.20.107G Boehringer Ingelheim Investigational Site
      • Rosiers d'Egletons, France
        • 1235.20.109A Boehringer Ingelheim Investigational Site
      • Saint Aulaire, France
        • 1235.20.109F Boehringer Ingelheim Investigational Site
      • Saint Etienne, France
        • 1235.20.104A Boehringer Ingelheim Investigational Site
      • Saint Etienne, France
        • 1235.20.104D Boehringer Ingelheim Investigational Site
      • Salies de Bearn, France
        • 1235.20.107F Boehringer Ingelheim Investigational Site
      • Toulon, France
        • 1235.20.105A Boehringer Ingelheim Investigational Site
      • Toulon, France
        • 1235.20.105D Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 1235.20.152 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1235.20.156 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1235.20.158 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1235.20.159 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1235.20.161 Boehringer Ingelheim Investigational Site
      • Gyongyos, Hungary
        • 1235.20.153 Boehringer Ingelheim Investigational Site
      • Miskolc, Hungary
        • 1235.20.154 Boehringer Ingelheim Investigational Site
      • Miskolc, Hungary
        • 1235.20.157 Boehringer Ingelheim Investigational Site
      • Mosonmagyarovar, Hungary
        • 1235.20.155 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of
        • 1235.20.207 Boehringer Ingelheim Investigational Site
      • Chunan, Korea, Republic of
        • 1235.20.206 Boehringer Ingelheim Investigational Site
      • Koyang, Korea, Republic of
        • 1235.20.205 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1235.20.201 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1235.20.202 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1235.20.203 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1235.20.204 Boehringer Ingelheim Investigational Site
  • Romania
      • Braila, Romania
        • 1235.20.252 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1235.20.259 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1235.20.262 Boehringer Ingelheim Investigational Site
      • Iasi, Romania
        • 1235.20.254 Boehringer Ingelheim Investigational Site
      • Oradea, Romania
        • 1235.20.261 Boehringer Ingelheim Investigational Site
      • Sibiu, Romania
        • 1235.20.256 Boehringer Ingelheim Investigational Site
      • Targu-Mures, Romania
        • 1235.20.251 Boehringer Ingelheim Investigational Site
      • Tg. Mures, Romania
        • 1235.20.260 Boehringer Ingelheim Investigational Site
      • Timisoara, Romania
        • 1235.20.253 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1235.20.301 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1235.20.302 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1235.20.303 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1235.20.304 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1235.20.310 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1235.20.305 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1235.20.306 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1235.20.307 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1235.20.308 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1235.20.309 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1235.20.311 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Galanta, Slovakia
        • 1235.20.355 Boehringer Ingelheim Investigational Site
      • Kosice, Slovakia
        • 1235.20.353 Boehringer Ingelheim Investigational Site
      • Povazska Bystrica, Slovakia
        • 1235.20.352 Boehringer Ingelheim Investigational Site
      • Rimavska Sobota, Slovakia
        • 1235.20.354 Boehringer Ingelheim Investigational Site
      • Trnava, Slovakia
        • 1235.20.356 Boehringer Ingelheim Investigational Site
      • Vrable, Slovakia
        • 1235.20.351 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 1235.20.406 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1235.20.408 Boehringer Ingelheim Investigational Site
      • Granada, Spain
        • 1235.20.402 Boehringer Ingelheim Investigational Site
      • Sevilla, Spain
        • 1235.20.403 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1235.20.409 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Kharkov, Ukraine
        • 1235.20.451 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.20.458 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.20.460 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.20.453 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.20.454 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.20.455 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.20.456 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.20.457 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.20.461 Boehringer Ingelheim Investigational Site
      • Lvov, Ukraine
        • 1235.20.452 Boehringer Ingelheim Investigational Site
      • Odessa, Ukraine
        • 1235.20.459 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • Buena Park, California, United States
        • 1235.20.525 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 1235.20.503 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 1235.20.507 Boehringer Ingelheim Investigational Site
      • Roseville, California, United States
        • 1235.20.529 Boehringer Ingelheim Investigational Site
      • Tustin, California, United States
        • 1235.20.518 Boehringer Ingelheim Investigational Site
      • Westlake Village, California, United States
        • 1235.20.521 Boehringer Ingelheim Investigational Site
    • Florida
      • DeLand, Florida, United States
        • 1235.20.508 Boehringer Ingelheim Investigational Site
      • Hialeah, Florida, United States
        • 1235.20.506 Boehringer Ingelheim Investigational Site
      • Pembroke Pines, Florida, United States
        • 1235.20.519 Boehringer Ingelheim Investigational Site
      • Port Orange, Florida, United States
        • 1235.20.523 Boehringer Ingelheim Investigational Site
    • Georgia
      • Blue Ridge, Georgia, United States
        • 1235.20.528 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States
        • 1235.20.516 Boehringer Ingelheim Investigational Site
    • Michigan
      • Bay City, Michigan, United States
        • 1235.20.527 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 1235.20.510 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • 1235.20.512 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, United States
        • 1235.20.509 Boehringer Ingelheim Investigational Site
    • Ohio
      • Kettering, Ohio, United States
        • 1235.20.511 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • 1235.20.515 Boehringer Ingelheim Investigational Site
    • Oregon
      • Medford, Oregon, United States
        • 1235.20.534 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, United States
        • 1235.20.526 Boehringer Ingelheim Investigational Site
      • Tipton, Pennsylvania, United States
        • 1235.20.513 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • 1235.20.517 Boehringer Ingelheim Investigational Site
    • Texas
      • Carrollton, Texas, United States
        • 1235.20.522 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1235.20.520 Boehringer Ingelheim Investigational Site
      • Killeen, Texas, United States
        • 1235.20.530 Boehringer Ingelheim Investigational Site
    • Utah
      • Draper, Utah, United States
        • 1235.20.535 Boehringer Ingelheim Investigational Site
      • Magna, Utah, United States
        • 1235.20.533 Boehringer Ingelheim Investigational Site
      • Saratoga Springs, Utah, United States
        • 1235.20.505 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, United States
        • 1235.20.537 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • 1235.20.501 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
  4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)

Exclusion criteria Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood Pressure [DBP] >/= 95 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: telmisartan and amlodipine
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Drug: telmisartan and amlodipine
telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w
ACTIVE_COMPARATOR: amlodipine
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Drug: amlodipine
amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w
ACTIVE_COMPARATOR: telmisartan
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Drug: telmisartan
telmisartan 80mg for the 8w, no titration required

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8
Time Frame: baseline and week 8
Overall mean reduction from a common mean baseline in SBP
baseline and week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6
Time Frame: baseline and week 6
Overall mean reduction from a common mean baseline in SBP
baseline and week 6
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4
Time Frame: baseline and week 4
Overall mean reduction from a common mean baseline in SBP
baseline and week 4
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2
Time Frame: baseline and week 2
Overall mean reduction from a common mean baseline in SBP
baseline and week 2
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1
Time Frame: baseline and week 1
Overall mean reduction from a common mean baseline in SBP
baseline and week 1
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8
Time Frame: baseline and week 8
Overall mean reduction from a common mean baseline in DBP
baseline and week 8
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6
Time Frame: baseline and week 6
Overall mean reduction from a common mean baseline in DBP
baseline and week 6
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4
Time Frame: baseline and week 4
Overall mean reduction from a common mean baseline in DBP
baseline and week 4
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2
Time Frame: baseline and week 2
Overall mean reduction from a common mean baseline in DBP
baseline and week 2
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1
Time Frame: baseline and week 1
Overall mean reduction from a common mean baseline in DBP
baseline and week 1
Patients Achieving Diastolic Blood Pressure Control at Week 1
Time Frame: week 1
Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg
week 1
Patients Achieving Diastolic Blood Pressure Control at Week 2
Time Frame: week 2
DBP < 90 mmHg
week 2
Patients Achieving Blood Pressure Control at Week 1
Time Frame: week 1
Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg
week 1
Patients Achieving Blood Pressure Control at Week 2
Time Frame: week 2
SBP < 140 mmHg and DBP < 90 mmHg
week 2
Patients Achieving Diastolic Blood Pressure Response at Week 1
Time Frame: baseline, week 1
Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg
baseline, week 1
Patients Achieving Diastolic Blood Pressure Response at Week 2
Time Frame: baseline, week 2
DBP < 90 mmHg or reduction of >= 10 mmHg
baseline, week 2
Patients Achieving Systolic Blood Pressure Response at Week 1
Time Frame: baseline, week 1
Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg
baseline, week 1
Patients Achieving Systolic Blood Pressure Response at Week 2
Time Frame: baseline, week 2
SBP < 140 mmHg or reduction of >= 15 mmHg
baseline, week 2
Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
Time Frame: week 1
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
week 1
Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
Time Frame: week 2
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
week 2
Patients Achieving Diastolic Blood Pressure Control at Week 4
Time Frame: week 4
DBP < 90 mmHg
week 4
Patients Achieving Diastolic Blood Pressure Control at Week 6
Time Frame: week 6
DBP < 90 mmHg
week 6
Patients Achieving Diastolic Blood Pressure Control at Week 8
Time Frame: week 8
DBP < 90 mmHg
week 8
Patients Achieving Blood Pressure Control at Week 4
Time Frame: week 4
SBP < 140 mmHg and DBP < 90 mmHg
week 4
Patients Achieving Blood Pressure Control at Week 6
Time Frame: week 6
SBP < 140 mmHg and DBP < 90 mmHg
week 6
Patients Achieving Blood Pressure Control at Week 8
Time Frame: week 8
SBP < 140 mmHg and DBP < 90 mmHg
week 8
Patients Achieving Diastolic Blood Pressure Response at Week 4
Time Frame: baseline, week 4
DBP < 90 mmHg or reduction of >= 10 mmHg
baseline, week 4
Patients Achieving Diastolic Blood Pressure Response at Week 6
Time Frame: baseline, week 6
DBP < 90 mmHg or reduction of >= 10 mmHg
baseline, week 6
Patients Achieving Diastolic Blood Pressure Response at Week 8
Time Frame: baseline, week 8
DBP < 90 mmHg or reduction of >= 10 mmHg
baseline, week 8
Patients Achieving Systolic Blood Pressure Response at Week 4
Time Frame: baseline, week 4
SBP < 140 mmHg or reduction of >= 15 mmHg
baseline, week 4
Patients Achieving Systolic Blood Pressure Response at Week 6
Time Frame: baseline, week 6
SBP < 140 mmHg or reduction of >= 15 mmHg
baseline, week 6
Patients Achieving Systolic Blood Pressure Response at Week 8
Time Frame: baseline, week 8
SBP < 140 mmHg or reduction of >= 15 mmHg
baseline, week 8
Patients Achieving Normal Blood Pressure Response at Week 4
Time Frame: week 4
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
week 4
Patients Achieving Normal Blood Pressure Response at Week 6
Time Frame: week 6
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
week 6
Patients Achieving Normal Blood Pressure Response at Week 8
Time Frame: week 8
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1235.20
  • 2008-000873-40 (EUDRACT_NUMBER: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on telmisartan and amlodipine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings