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Completed

NCT Number: NCT01103960

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1235.29.86001 Boehringer Ingelheim Investigational Site, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of essential hypertension
  • failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
  • provision of written informed consent

Exclusion criteria

  • 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)

Treatment and study plan

Telmisartan80mg+Amlodipine5mg

Drug

combination therapy

Amlodipine 5mg

Drug

monotherapy

Telmisartan80mg+Amlodipine 5mg

Drug

combination therapy

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Change From Baseline in DBP After 4 Weeks of Treatment

    Time frame: Baseline and 4 weeks

    Seated trough DBP after 4 weeks.

  5. Change From Baseline in SBP After 4 Weeks of Treatment

    Time frame: Baseline and 4 weeks

    Seated trough SBP after 4 weeks.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
First posted
Apr 15, 2010
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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