An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

• ClinicalTrials.gov Identifier: NCT00618774
• Recruitment Status: Completed
• First Posted: February 20, 2008
• Results First Posted: March 3, 2010
• Last Update Posted: June 27, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by: Boehringer Ingelheim

Study Description

Brief Summary:

To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: telmisartan40/amlodipine5; Drug: telmisartan80/amlodipine5	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 259 participants
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• Official Title: An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
• Study Start Date: January 2008
• Actual Primary Completion Date: October 2009

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Experienced Adverse Events [ Time Frame: 52 weeks ]
   An adverse event is defined as any untoward medical occurrence
2. Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG [ Time Frame: First administration of study treatment to 24 hours post last dosing of study treatment. ]
   Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.

Secondary Outcome Measures :

1. Change From Baseline in Seated Diastolic Blood Pressure at Week 8 [ Time Frame: Baseline and week 8 ]
   mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
2. Change From Baseline in Seated Systolic Blood Pressure at Week 8 [ Time Frame: Baseline and week 8 ]
   mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
3. Seated DBP Control Rate at Trough After 8 Weeks [ Time Frame: week 8 ]
   Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment
4. Seated SBP Control Rate at Trough After 8 Weeks [ Time Frame: Week 8 ]
   Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment
5. Change From Baseline in Seated Diastolic Blood Pressure [ Time Frame: Baseline and week 20 / week 48 ]
   Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
6. Change From Baseline in Seated Systolic Blood Pressure [ Time Frame: Baseline and week 20 / week 48 ]
   mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
7. Seated DBP Control Rate at Trough After 6 and 12 Months [ Time Frame: 6 months and 12 months ]
   Percentage of patients whose DBP <90 mmHg.
8. Seated SBP Control Rate at Trough After 6 and 12 Months [ Time Frame: 6 months and 12 months ]
   Percentage of patients whose SBP <140 mmHg
9. Seated DBP Response Rate at Trough [ Time Frame: 6 months and 12 months ]
   Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months
10. Seated SBP Response Rate at Trough [ Time Frame: 6 months and 12 months ]
    Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months
11. Seated Blood Pressure Normalisation at Trough [ Time Frame: 6 months and 12 months ]

    Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months:

    Optimal: SBP <120 mmHg and DBP <80 mmHg

    Normal: SBP >=120 mmHg or DBP >=80 mmHg and SBP <130 mmHg or DBP <85 mmHg

    High normal: SBP >=130 mmHg or DBP >=85 mmHg and SBP <140 mmHg or DBP <90 mmHg

    No: SBP >=140 mmHg or DBP >=90 mmHg

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patients with essential hypertension
2. Outpatient

Exclusion Criteria:

• Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
• Patients who have met any of the exclusion criteria defined in the "non-responder trials"

Contacts and Locations

Locations

Japan

1235.16.004 Boehringer Ingelheim Investigational Site

Chofu, Tokyo, Japan

1235.16.006 Boehringer Ingelheim Investigational Site

Nishi-ku, Hiroshima, Hiroshima, Japan

1235.16.005 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

1235.16.007 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

1235.16.003 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

1235.16.001 Boehringer Ingelheim Investigational Site

Shinjyuku-ku,Tokyo, Japan

1235.16.002 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT00618774
• Other Study ID Numbers: 1235.16
• First Posted: February 20, 2008
• Results First Posted: March 3, 2010
• Last Update Posted: June 27, 2014
• Last Verified: April 2014

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Amlodipine; Telmisartan; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists