An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

Overview

The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.

Full Title of Study: “8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: August 2011

Interventions

  • Drug: Telmisartan80mg+Amlodipine5mg
    • combination therapy
  • Drug: amlodipine 5mg
    • monotherapy
  • Drug: Telmisartan80mg+Amlodipine 5mg
    • combination therapy

Arms, Groups and Cohorts

  • Experimental: Telmisartan80mg+Amlodipine5mg
    • combination therapy
  • Active Comparator: amlodipine 5 mg
    • Monotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in DBP After 8 Weeks of Treatment
    • Time Frame: Baseline and 8 weeks
    • Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
  • Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
    • Time Frame: Baseline and 8 weeks
    • Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.

Secondary Measures

  • Change From Baseline in SBP After 8 Weeks of Treatment
    • Time Frame: Baseline and 8 weeks
    • Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
  • DBP and SBP Control and Response After 8 Weeks of Treatment
    • Time Frame: Baseline and 8 weeks
    • DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.
  • Number of Patients in Blood Pressure Categories Over Time
    • Time Frame: 8 weeks
    • BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.
  • Change From Baseline in DBP After 4 Weeks of Treatment
    • Time Frame: Baseline and 4 weeks
    • Seated trough DBP after 4 weeks.
  • Change From Baseline in SBP After 4 Weeks of Treatment
    • Time Frame: Baseline and 4 weeks
    • Seated trough SBP after 4 weeks.
  • DBP and SBP Control and Response After 4 Weeks of Treatment
    • Time Frame: Baseline and 4 weeks
    • DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.
  • Number of Patients in Blood Pressure Categories at 4 Weeks
    • Time Frame: 4 weeks
    • BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.
  • Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.
    • Time Frame: From drug administration until end of treatment plus one day
    • Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Participating in This Clinical Trial

Inclusion Criteria

1. diagnosis of essential hypertension 2. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy 3. provision of written informed consent Exclusion criteria:

1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

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