NCT00624052CompletedPhase 3
An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 838
- Locations
- 131
- Primary Endpoint
- Trough Seated Diastolic Blood Pressure (DBP) Control
Study Overview
Brief Summary
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.
An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.
The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of essential hypertension
Exclusion Criteria
- •pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
- •development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
- •discontinuation from the preceding trial.
- •known or suspected secondary hypertension.
- •mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic blood pressure (DBP) >= 120 mmHg at any visit.
- •any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
- •clinically relevant hyperkalaemia.
- •uncorrected volume or sodium depletion.
- •primary aldosteronism.
- •hereditary fructose or lactose intolerance.
- •symptomatic congestive heart failure.
- •patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
- •any new drug or alcohol dependency since signing consent of the preceding trial.
- •concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
- •hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
- •known allergic hypersensitivity to any component of the formulations under investigation. [Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).] non-compliance with study medication (defined as <80% or >120%) during the preceding trial.
- •administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
Outcomes
Primary Outcomes
Trough Seated Diastolic Blood Pressure (DBP) Control
Time Frame: End of study (34 weeks or last value on treatment)
The number of patients who reached the target DBP of \<90mmHg
Secondary Outcomes
- Trough Seated Systolic Blood Pressure (SBP) Control(End of study (34 weeks or last value on treatment))
- Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure(Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment)
- Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052(Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment))
- Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure(Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment)
- Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052(Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment))
- Trough Seated DBP Response(End of study (34 weeks or last value on treatment))
- Trough Seated SBP Response(End of study (34 weeks or last value on treatment))
- Trough BP Normality Classes(End of study (34 weeks or last value on treatment))
- Time to First Additional Antihypertensive(up to 34 weeks)
- Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control(up to 34 weeks)
- Additional Reduction in DBP by Use of Additional Antihypertensive Therapy(up to 34 weeks)
- Additional Reduction in SBP by Use of Additional Antihypertensive Therapy(up to 34 weeks)
- Trough DBP Control Pre- and Post- Uptitration(up to 34 weeks)
Investigators
Study Sites (131)
Loading locations...
Similar Trials
Completed
Phase 3
Open Label Study Telmisartan and Amlodipine in HypertensionHypertensionNCT00614380Boehringer Ingelheim976
Unknown
Phase 1
Clinical Trial to Assess Safety and Efficacy of Combination Therapy: Hydroxychloroquine, Pegylated Interferon Alpha-2a and Ribavirin in Chronic Hepatitis C Subjects Non-responders to the Standard of Care Therapy.Chronic Hepatitis CNCT01272310Sheba Medical Center36
Recruiting
Phase 3
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 MutationMetastatic Breast CancerNCT05696626LeonaBio600
Completed
Phase 4
Tuberculosis and Human Immunodeficiency Virus (HIV) Immune Reconstitution Syndrome Trial (THIRST)HIVTuberculosisNCT00851630Duke University70
Completed
Phase 1
Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female SubjectsHealthyNCT01737996Boehringer Ingelheim32