Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension
This study has been completed.
Sponsor:
Hanmi Pharmaceutical Company Limited
Information provided by:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01127217
First received: May 19, 2010
Last updated: September 12, 2010
Last verified: September 2010
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The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: amlodipine/losartan Drug: amlodipine |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Official Title: | The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension |
Resource links provided by NLM:
Further study details as provided by Hanmi Pharmaceutical Company Limited:
Primary Outcome Measures:
- Change from baseline in MSSBP [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in MSSBP [ Time Frame: Baseline, Week 2 and 8 ] [ Designated as safety issue: No ]
- Change from baseline MSDBP [ Time Frame: Baseline, Week 2, 6, and 8 ] [ Designated as safety issue: No ]
- Blood pressure responder rate [ Time Frame: Baseline, Week 2, 6, 8 ] [ Designated as safety issue: No ]Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg or MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline.
Enrollment: | 149 |
Study Start Date: | May 2009 |
Study Completion Date: | March 2010 |
Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: amlodipine/losartan |
Drug: amlodipine/losartan
amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)
Other Name: amosartan
|
Active Comparator: amlodipine |
Drug: amlodipine
amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)
Other Name: amodipin(amlodipine camsylate)
|
![](https://webarchive.library.unt.edu/web/20121019002215im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 aged or over
- Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
- Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg
Exclusion Criteria:
- Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
- ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
- History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
- Secondary hypertension or suspected to be
- Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months
- Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus
- History of severe neurovascular disease, severe heart disease
- Known as moderate or malignant retinopathy.
- Renal diseases; serum creatinine ≥ 2mg/dl
- Hepatic diseases; increase in ALT or AST ≥ 2xUNL
- Anuria
- Hyponatremia/hypokalemia or hypercalcemia
- Active Gout
- Surgical or medical diseases which might significantly change ADME of medicines
- History of malignant tumor
- Autoimmune diseases
- History of alcohol or drug abuse
- Positive to pregnancy test, nursing mother, woman with an intention of pregnancy
- Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision
Other protocol-defined inclusion/exclusion criteria may apply
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No publications provided
ClinicalTrials.gov Identifier: | NCT01127217 History of Changes |
Other Study ID Numbers: | HM-ALOS-303 |
Study First Received: | May 19, 2010 |
Last Updated: | September 12, 2010 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Hanmi Pharmaceutical Company Limited:
amlodipine losartan hypertension stage 2 |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Losartan Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on October 17, 2012